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Polypectomy Best Practices Not Routinely Followed in US
, an analysis of more than 1.8 million colonoscopies found.
“We expected to find some variations in polypectomy technique, but the results were surprising; overall, cold snare usage was much lower than expected, given that this is the recommended method for removing most small polyps,” Seth Crockett, MD, MPH, AGAF, professor of medicine, Division of Gastroenterology and Hepatology, Oregon Health & Science University, Portland, told GI & Hepatology News.
The study was published in the October issue of The American Journal of Gastroenterology.
Using Gastroenterology Quality Improvement Consortium Registry data, Crockett and colleagues analyzed more than 1.8 million colonoscopies performed by 4601 endoscopists between 2019 and 2022 across 702 sites. All colonoscopies involved removal of polyps < 1 cm; lesions of this size are commonly found in screening colonoscopies, and detection is crucial to early cancer prevention.
The researchers found striking variation in polypectomy technique. Guideline-based cold snare polypectomy (CSP) was used in only 58% of cases (and as a single device in only 51%), whereas cold forceps polypectomy (CFP) accounted for 35% and hot snare polypectomy (HSP) for 11%.
The fact that CSP was used in fewer than 60% of cases represents “an important quality gap,” the authors wrote, adding that the fact that more than 10% of colonoscopies used HSP suggests that “some patients harboring low-risk lesions may be exposed to excess risk related to these practice variations.”
And while recommendations around the use of CFP are more nuanced (based largely on forceps type and polyp size), the “high frequency of CFP also suggests nonadherence to best practices,” they noted.
Gastroenterologists More Apt to Follow Guidance
Polypectomy technique varied by polyp type. CFP was more common in cases where only hyperplastic polyps were removed compared with cases with tubular adenomas (45% vs 30%, respectively). CSP use was highest in cases where only sessile serrated lesions were removed (66%) compared with cases with only tubular adenomas (61%) or hyperplastic polyps (37%).
There was also considerable variation by provider specialty.
Gastroenterologists (compared with non-GI specialists) used HSP less (4% vs 8%) and CSP more (40% vs 34%). Colonoscopies performed with GI fellows were more likely to use CFP (31% vs 21%) and less likely to use HSP (1% vs 5%) compared with colonoscopies without fellows.
“It was somewhat reassuring that colonoscopies performed by gastroenterologists were more likely to adhere to guideline recommendations, which suggests that dedicated endoscopy training is likely an important factor driving high-quality colonoscopy,” Crockett told GI & Hepatology News.
“Unexpectedly,” polypectomy technique also differed dramatically by geographic region, he said. CFP was used more than twice as often in the Northeast (31%) as in the Midwest (14%), whereas CSP was used more frequently in the Midwest (52%) than in the Northeast (32%).
“We suspect that much of the variation is related to differences in training, preferences, habits, and evolution of colonoscopy practice over time,” Crockett said. “More research is needed on the underlying drivers of this variation, and how differences in polypectomy technique impact both the safety and efficacy of colonoscopy to prevent colorectal cancer,” he said.
“As a specialty, we need to continue to work on disseminating guideline recommendations regarding colonoscopy quality, monitoring adherence to evidence-based practices, and working to address gaps in quality where they exist,” he added.
‘Concerning, Surprising, and Disappointing’
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School and Old Dominion University in Norfolk, called the results “concerning, surprising, and disappointing” and not consistent with the most current quality recommendations that advocate cold snare for most polyps less than 1 cm in size.
“Cold snare polypectomy has been shown not only to be more effective but also takes less time to perform, relative to cold biopsy,” said Johnson, who wasn’t involved in the study.
Johnson told GI & Hepatology News, “Inadequate lesion resection and variation in resection quality are major issues for colonoscopy quality. Those who perform colonoscopies need to be up-to-date with evidence-based quality standards — as well as held accountable if [there is] discordant practice — if we are to optimize the cancer prevention benefits of quality colonoscopy.”
Limitations of the current analysis include lack of extensive patient information and inability to further stratify polyps < 1 cm by size.
The study had no commercial funding. Crockett had no disclosures. Johnson disclosed serving as a director, officer, partner, employee, advisor, consultant, or trustee for ISOThrive.
A version of this article appeared on Medscape.com.
, an analysis of more than 1.8 million colonoscopies found.
“We expected to find some variations in polypectomy technique, but the results were surprising; overall, cold snare usage was much lower than expected, given that this is the recommended method for removing most small polyps,” Seth Crockett, MD, MPH, AGAF, professor of medicine, Division of Gastroenterology and Hepatology, Oregon Health & Science University, Portland, told GI & Hepatology News.
The study was published in the October issue of The American Journal of Gastroenterology.
Using Gastroenterology Quality Improvement Consortium Registry data, Crockett and colleagues analyzed more than 1.8 million colonoscopies performed by 4601 endoscopists between 2019 and 2022 across 702 sites. All colonoscopies involved removal of polyps < 1 cm; lesions of this size are commonly found in screening colonoscopies, and detection is crucial to early cancer prevention.
The researchers found striking variation in polypectomy technique. Guideline-based cold snare polypectomy (CSP) was used in only 58% of cases (and as a single device in only 51%), whereas cold forceps polypectomy (CFP) accounted for 35% and hot snare polypectomy (HSP) for 11%.
The fact that CSP was used in fewer than 60% of cases represents “an important quality gap,” the authors wrote, adding that the fact that more than 10% of colonoscopies used HSP suggests that “some patients harboring low-risk lesions may be exposed to excess risk related to these practice variations.”
And while recommendations around the use of CFP are more nuanced (based largely on forceps type and polyp size), the “high frequency of CFP also suggests nonadherence to best practices,” they noted.
Gastroenterologists More Apt to Follow Guidance
Polypectomy technique varied by polyp type. CFP was more common in cases where only hyperplastic polyps were removed compared with cases with tubular adenomas (45% vs 30%, respectively). CSP use was highest in cases where only sessile serrated lesions were removed (66%) compared with cases with only tubular adenomas (61%) or hyperplastic polyps (37%).
There was also considerable variation by provider specialty.
Gastroenterologists (compared with non-GI specialists) used HSP less (4% vs 8%) and CSP more (40% vs 34%). Colonoscopies performed with GI fellows were more likely to use CFP (31% vs 21%) and less likely to use HSP (1% vs 5%) compared with colonoscopies without fellows.
“It was somewhat reassuring that colonoscopies performed by gastroenterologists were more likely to adhere to guideline recommendations, which suggests that dedicated endoscopy training is likely an important factor driving high-quality colonoscopy,” Crockett told GI & Hepatology News.
“Unexpectedly,” polypectomy technique also differed dramatically by geographic region, he said. CFP was used more than twice as often in the Northeast (31%) as in the Midwest (14%), whereas CSP was used more frequently in the Midwest (52%) than in the Northeast (32%).
“We suspect that much of the variation is related to differences in training, preferences, habits, and evolution of colonoscopy practice over time,” Crockett said. “More research is needed on the underlying drivers of this variation, and how differences in polypectomy technique impact both the safety and efficacy of colonoscopy to prevent colorectal cancer,” he said.
“As a specialty, we need to continue to work on disseminating guideline recommendations regarding colonoscopy quality, monitoring adherence to evidence-based practices, and working to address gaps in quality where they exist,” he added.
‘Concerning, Surprising, and Disappointing’
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School and Old Dominion University in Norfolk, called the results “concerning, surprising, and disappointing” and not consistent with the most current quality recommendations that advocate cold snare for most polyps less than 1 cm in size.
“Cold snare polypectomy has been shown not only to be more effective but also takes less time to perform, relative to cold biopsy,” said Johnson, who wasn’t involved in the study.
Johnson told GI & Hepatology News, “Inadequate lesion resection and variation in resection quality are major issues for colonoscopy quality. Those who perform colonoscopies need to be up-to-date with evidence-based quality standards — as well as held accountable if [there is] discordant practice — if we are to optimize the cancer prevention benefits of quality colonoscopy.”
Limitations of the current analysis include lack of extensive patient information and inability to further stratify polyps < 1 cm by size.
The study had no commercial funding. Crockett had no disclosures. Johnson disclosed serving as a director, officer, partner, employee, advisor, consultant, or trustee for ISOThrive.
A version of this article appeared on Medscape.com.
, an analysis of more than 1.8 million colonoscopies found.
“We expected to find some variations in polypectomy technique, but the results were surprising; overall, cold snare usage was much lower than expected, given that this is the recommended method for removing most small polyps,” Seth Crockett, MD, MPH, AGAF, professor of medicine, Division of Gastroenterology and Hepatology, Oregon Health & Science University, Portland, told GI & Hepatology News.
The study was published in the October issue of The American Journal of Gastroenterology.
Using Gastroenterology Quality Improvement Consortium Registry data, Crockett and colleagues analyzed more than 1.8 million colonoscopies performed by 4601 endoscopists between 2019 and 2022 across 702 sites. All colonoscopies involved removal of polyps < 1 cm; lesions of this size are commonly found in screening colonoscopies, and detection is crucial to early cancer prevention.
The researchers found striking variation in polypectomy technique. Guideline-based cold snare polypectomy (CSP) was used in only 58% of cases (and as a single device in only 51%), whereas cold forceps polypectomy (CFP) accounted for 35% and hot snare polypectomy (HSP) for 11%.
The fact that CSP was used in fewer than 60% of cases represents “an important quality gap,” the authors wrote, adding that the fact that more than 10% of colonoscopies used HSP suggests that “some patients harboring low-risk lesions may be exposed to excess risk related to these practice variations.”
And while recommendations around the use of CFP are more nuanced (based largely on forceps type and polyp size), the “high frequency of CFP also suggests nonadherence to best practices,” they noted.
Gastroenterologists More Apt to Follow Guidance
Polypectomy technique varied by polyp type. CFP was more common in cases where only hyperplastic polyps were removed compared with cases with tubular adenomas (45% vs 30%, respectively). CSP use was highest in cases where only sessile serrated lesions were removed (66%) compared with cases with only tubular adenomas (61%) or hyperplastic polyps (37%).
There was also considerable variation by provider specialty.
Gastroenterologists (compared with non-GI specialists) used HSP less (4% vs 8%) and CSP more (40% vs 34%). Colonoscopies performed with GI fellows were more likely to use CFP (31% vs 21%) and less likely to use HSP (1% vs 5%) compared with colonoscopies without fellows.
“It was somewhat reassuring that colonoscopies performed by gastroenterologists were more likely to adhere to guideline recommendations, which suggests that dedicated endoscopy training is likely an important factor driving high-quality colonoscopy,” Crockett told GI & Hepatology News.
“Unexpectedly,” polypectomy technique also differed dramatically by geographic region, he said. CFP was used more than twice as often in the Northeast (31%) as in the Midwest (14%), whereas CSP was used more frequently in the Midwest (52%) than in the Northeast (32%).
“We suspect that much of the variation is related to differences in training, preferences, habits, and evolution of colonoscopy practice over time,” Crockett said. “More research is needed on the underlying drivers of this variation, and how differences in polypectomy technique impact both the safety and efficacy of colonoscopy to prevent colorectal cancer,” he said.
“As a specialty, we need to continue to work on disseminating guideline recommendations regarding colonoscopy quality, monitoring adherence to evidence-based practices, and working to address gaps in quality where they exist,” he added.
‘Concerning, Surprising, and Disappointing’
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School and Old Dominion University in Norfolk, called the results “concerning, surprising, and disappointing” and not consistent with the most current quality recommendations that advocate cold snare for most polyps less than 1 cm in size.
“Cold snare polypectomy has been shown not only to be more effective but also takes less time to perform, relative to cold biopsy,” said Johnson, who wasn’t involved in the study.
Johnson told GI & Hepatology News, “Inadequate lesion resection and variation in resection quality are major issues for colonoscopy quality. Those who perform colonoscopies need to be up-to-date with evidence-based quality standards — as well as held accountable if [there is] discordant practice — if we are to optimize the cancer prevention benefits of quality colonoscopy.”
Limitations of the current analysis include lack of extensive patient information and inability to further stratify polyps < 1 cm by size.
The study had no commercial funding. Crockett had no disclosures. Johnson disclosed serving as a director, officer, partner, employee, advisor, consultant, or trustee for ISOThrive.
A version of this article appeared on Medscape.com.
Colon Cleanses: How to Discourage Patients
Social media is rife with content promoting colon cleansing as a way to shed toxins and fix everything from chronic fatigue and overweight to weak immunity and skin problems.
Even doctors who aren’t hip to the latest TikTok trends may not be able to avoid the hype. That’s because patients are bringing up colon cleansing during their office visit.
“Patients often raise questions about colonics or detox teas, especially when these gain traction on social media platforms like TikTok,” said Tauseef Ali, MD, AGAF, medical executive director of SSM Health Digestive Care at St. Anthony Hospital in Oklahoma City. “Interest typically comes in waves, closely tied to the latest online trends.”
That means . And it’s not just patients who are asking.
“Sometimes we’ll get a message from primary care,” Mohammad Bilal, MD, associate professor of medicine and director of Bariatric and Third Space Endoscopy at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, told GI & Hepatology News. They’re getting the same questions from patients, and they want to know if colon cleansing that’s not connected with a colonoscopy exam has any benefits for overall health or specific health conditions.
The answer is no, and patients are more likely to believe that when physicians explain it using good information. Here is how Ali, Bilal, and professional organizations advise doctors to approach the issue.
What Exactly Is a Colon Cleanse?
Colon cleanses come in a variety of forms. Colonic irrigation, also called colon hydrotherapy, involves inserting a tube into the rectum and flushing out the colon with a large amount of fluid. Enemas do the same but use a small amount of liquid, and some product instructions tell the user to “hold it” for a designated amount of time before expelling colon contents.
Other cleanses, often called detoxing cleanses, are laxatives or herbal teas that users drink — and then stay close to the bathroom. Detox regimens and diets also are mentioned as a way to remove toxins from the body, improve health, and promote well-being.
Why Do Patients Use Them?
“Many patients describe a desire for ‘cleanliness,’ ‘detoxification,’ or to ‘feel lighter,’” Ali told GI & Hepatology News.
The claims on social media promote all of this and more — and well-known influencers make it all sound even more attractive.
“These motivations are often rooted in the cultural belief that the colon accumulates harmful toxins that must be flushed out,” Ali said. “This idea is not supported by scientific evidence. The body’s natural detox systems, primarily the liver and kidneys, already perform this function effectively.”
Bilal said that in recent years, he has noticed more awareness in general about the importance of gut health. “When there’s awareness, people often go to the other extreme,” he said.
Where Is the Evidence?
The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, warns on an information page that both cleansing and detox programs can be unsafe and falsely advertised.
While searches of medical literature turn up few studies, the NCCIH information points to a 2014 review that concluded that there is no compelling research to support the use of detox diets for managing weight or eliminating toxins. A 2017 review found juicing and detox regimens can cause weight loss initially but then lead to weight gain once a normal diet is resumed.
A systematic review of research on the safety and effectiveness of self-administered coffee enemas found nine case reports describing adverse events: seven reported colitis after the enema, and two reported more critical adverse events. All nine reports warned against the procedure. The researchers found no study reporting the effectiveness of coffee enemas.
The NCCIH information also notes that there is “limited clinical evidence validating colonic irrigation and insufficient evidence for its prescribed uses.”
Are Cleanses Regulated?
Some over-the-counter colon cleansing products are viewed as dietary supplements, giving the FDA authority to regulate them and take action under the Dietary Supplement Health and Education Act of 1994.
Certain products promoted as colon cleanses, such as laxatives, are regulated by the FDA as over-the-counter drugs and must meet safety and other requirements.
Colonic irrigation systems meant for cleansing before radiologic or endoscopic exams are class II devices — subject to 510(k) premarket notification requirements before marketing — whereas systems intended for other uses, such as routine colon cleansing for general well-being, are regarded as class III devices — subject to premarket approval requirements — according to an FDA spokesperson. To date, the FDA has not approved any colonic irrigation devices for the latter use, the spokesperson said.
For instance, the FDA warned consumers not to use a product promoted for colon cleansing after finding it contained tadalafil, the active ingredient in an FDA-approved drug for erectile dysfunction. The FDA has also issued numerous warning letters to the makers of colon cleansing devices, as they are not approved for this purpose.
The Federal Trade Commission can also take action specifically if the claims about the benefits and safety of products — including supplements, foods, over-the-counter drugs, or health equipment — are false, misleading, or not supported by science.
What Are the Dangers?
Cleanse and detox products come with many risks, including electrolyte imbalances, dehydration, and infections, Ali said. With colonic irrigation, there is a risk for rectal perforation. Products also may disrupt the gut microbiome, and some can interact with medications or worsen underlying health conditions, he added.
“It’s important for patients to be aware of these risks before considering nonmedical ‘cleaning’ methods,” he said.
At worst, patients risk fatality, Ali noted. He recalled a young patient who began using a vegetable enema as a detox. As it was being administered, the colon ruptured. The patient was admitted as a medical emergency and required surgery. Fortunately, the patient survived, but the incident could have proven fatal, Ali said.
Educating Patients
Because patients often don’t think of herbal cleanses, detox teas, and over-the-counter powders as supplements, Ali said it’s important to ask them about everything they take.
One way to frame this question is to ask if they are consuming any over-the-counter supplements or any other remedies, he said, and perhaps ask directly about any cleanses they are doing.
When patients ask him about colon cleanses, Ali explains the difference between evidence-based colonoscopy preparation and unregulated “cleanses.” Most patients respond to that approach, he said. Indeed, AGA and other GI societies updated their recommendations on optimizing bowel preparation quality for colonoscopy.
“Still, the appeal of quick fixes of social media trends can sometimes outweigh medical advice,” Ali said. He depends on building trusted relationships and reinforcing the message over time and finds that helps patients make informed and healthier choices.
Bilal, too, explains to patients that cleanses are unnecessary and educates them about what to do instead:
- Eat a containing the recommended amount of (22-34 g, depending on age and gender).
- For , follow a bowel regimen advised by your doctor.
- If gastrointestinal issues persist, get a medical checkup.
- Get any unexplained constipation or checked out by a doctor.
Taking a careful history can pay off, Ali has found. He questioned a patient complaining of abdominal discomfort whose testing found unexpectedly elevated liver enzymes and found she had been using an herbal “cleanse tea” found online. Within 4 weeks of stopping it, her liver enzymes normalized. “Thankfully, she made a full recovery — and she never touched those remedies again,” he said.
Ali had no relevant disclosures. Bilal reported consulting for Boston Scientific, Cook Medical, and Steris.
A version of this article appeared on Medscape.com.
Social media is rife with content promoting colon cleansing as a way to shed toxins and fix everything from chronic fatigue and overweight to weak immunity and skin problems.
Even doctors who aren’t hip to the latest TikTok trends may not be able to avoid the hype. That’s because patients are bringing up colon cleansing during their office visit.
“Patients often raise questions about colonics or detox teas, especially when these gain traction on social media platforms like TikTok,” said Tauseef Ali, MD, AGAF, medical executive director of SSM Health Digestive Care at St. Anthony Hospital in Oklahoma City. “Interest typically comes in waves, closely tied to the latest online trends.”
That means . And it’s not just patients who are asking.
“Sometimes we’ll get a message from primary care,” Mohammad Bilal, MD, associate professor of medicine and director of Bariatric and Third Space Endoscopy at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, told GI & Hepatology News. They’re getting the same questions from patients, and they want to know if colon cleansing that’s not connected with a colonoscopy exam has any benefits for overall health or specific health conditions.
The answer is no, and patients are more likely to believe that when physicians explain it using good information. Here is how Ali, Bilal, and professional organizations advise doctors to approach the issue.
What Exactly Is a Colon Cleanse?
Colon cleanses come in a variety of forms. Colonic irrigation, also called colon hydrotherapy, involves inserting a tube into the rectum and flushing out the colon with a large amount of fluid. Enemas do the same but use a small amount of liquid, and some product instructions tell the user to “hold it” for a designated amount of time before expelling colon contents.
Other cleanses, often called detoxing cleanses, are laxatives or herbal teas that users drink — and then stay close to the bathroom. Detox regimens and diets also are mentioned as a way to remove toxins from the body, improve health, and promote well-being.
Why Do Patients Use Them?
“Many patients describe a desire for ‘cleanliness,’ ‘detoxification,’ or to ‘feel lighter,’” Ali told GI & Hepatology News.
The claims on social media promote all of this and more — and well-known influencers make it all sound even more attractive.
“These motivations are often rooted in the cultural belief that the colon accumulates harmful toxins that must be flushed out,” Ali said. “This idea is not supported by scientific evidence. The body’s natural detox systems, primarily the liver and kidneys, already perform this function effectively.”
Bilal said that in recent years, he has noticed more awareness in general about the importance of gut health. “When there’s awareness, people often go to the other extreme,” he said.
Where Is the Evidence?
The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, warns on an information page that both cleansing and detox programs can be unsafe and falsely advertised.
While searches of medical literature turn up few studies, the NCCIH information points to a 2014 review that concluded that there is no compelling research to support the use of detox diets for managing weight or eliminating toxins. A 2017 review found juicing and detox regimens can cause weight loss initially but then lead to weight gain once a normal diet is resumed.
A systematic review of research on the safety and effectiveness of self-administered coffee enemas found nine case reports describing adverse events: seven reported colitis after the enema, and two reported more critical adverse events. All nine reports warned against the procedure. The researchers found no study reporting the effectiveness of coffee enemas.
The NCCIH information also notes that there is “limited clinical evidence validating colonic irrigation and insufficient evidence for its prescribed uses.”
Are Cleanses Regulated?
Some over-the-counter colon cleansing products are viewed as dietary supplements, giving the FDA authority to regulate them and take action under the Dietary Supplement Health and Education Act of 1994.
Certain products promoted as colon cleanses, such as laxatives, are regulated by the FDA as over-the-counter drugs and must meet safety and other requirements.
Colonic irrigation systems meant for cleansing before radiologic or endoscopic exams are class II devices — subject to 510(k) premarket notification requirements before marketing — whereas systems intended for other uses, such as routine colon cleansing for general well-being, are regarded as class III devices — subject to premarket approval requirements — according to an FDA spokesperson. To date, the FDA has not approved any colonic irrigation devices for the latter use, the spokesperson said.
For instance, the FDA warned consumers not to use a product promoted for colon cleansing after finding it contained tadalafil, the active ingredient in an FDA-approved drug for erectile dysfunction. The FDA has also issued numerous warning letters to the makers of colon cleansing devices, as they are not approved for this purpose.
The Federal Trade Commission can also take action specifically if the claims about the benefits and safety of products — including supplements, foods, over-the-counter drugs, or health equipment — are false, misleading, or not supported by science.
What Are the Dangers?
Cleanse and detox products come with many risks, including electrolyte imbalances, dehydration, and infections, Ali said. With colonic irrigation, there is a risk for rectal perforation. Products also may disrupt the gut microbiome, and some can interact with medications or worsen underlying health conditions, he added.
“It’s important for patients to be aware of these risks before considering nonmedical ‘cleaning’ methods,” he said.
At worst, patients risk fatality, Ali noted. He recalled a young patient who began using a vegetable enema as a detox. As it was being administered, the colon ruptured. The patient was admitted as a medical emergency and required surgery. Fortunately, the patient survived, but the incident could have proven fatal, Ali said.
Educating Patients
Because patients often don’t think of herbal cleanses, detox teas, and over-the-counter powders as supplements, Ali said it’s important to ask them about everything they take.
One way to frame this question is to ask if they are consuming any over-the-counter supplements or any other remedies, he said, and perhaps ask directly about any cleanses they are doing.
When patients ask him about colon cleanses, Ali explains the difference between evidence-based colonoscopy preparation and unregulated “cleanses.” Most patients respond to that approach, he said. Indeed, AGA and other GI societies updated their recommendations on optimizing bowel preparation quality for colonoscopy.
“Still, the appeal of quick fixes of social media trends can sometimes outweigh medical advice,” Ali said. He depends on building trusted relationships and reinforcing the message over time and finds that helps patients make informed and healthier choices.
Bilal, too, explains to patients that cleanses are unnecessary and educates them about what to do instead:
- Eat a containing the recommended amount of (22-34 g, depending on age and gender).
- For , follow a bowel regimen advised by your doctor.
- If gastrointestinal issues persist, get a medical checkup.
- Get any unexplained constipation or checked out by a doctor.
Taking a careful history can pay off, Ali has found. He questioned a patient complaining of abdominal discomfort whose testing found unexpectedly elevated liver enzymes and found she had been using an herbal “cleanse tea” found online. Within 4 weeks of stopping it, her liver enzymes normalized. “Thankfully, she made a full recovery — and she never touched those remedies again,” he said.
Ali had no relevant disclosures. Bilal reported consulting for Boston Scientific, Cook Medical, and Steris.
A version of this article appeared on Medscape.com.
Social media is rife with content promoting colon cleansing as a way to shed toxins and fix everything from chronic fatigue and overweight to weak immunity and skin problems.
Even doctors who aren’t hip to the latest TikTok trends may not be able to avoid the hype. That’s because patients are bringing up colon cleansing during their office visit.
“Patients often raise questions about colonics or detox teas, especially when these gain traction on social media platforms like TikTok,” said Tauseef Ali, MD, AGAF, medical executive director of SSM Health Digestive Care at St. Anthony Hospital in Oklahoma City. “Interest typically comes in waves, closely tied to the latest online trends.”
That means . And it’s not just patients who are asking.
“Sometimes we’ll get a message from primary care,” Mohammad Bilal, MD, associate professor of medicine and director of Bariatric and Third Space Endoscopy at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, told GI & Hepatology News. They’re getting the same questions from patients, and they want to know if colon cleansing that’s not connected with a colonoscopy exam has any benefits for overall health or specific health conditions.
The answer is no, and patients are more likely to believe that when physicians explain it using good information. Here is how Ali, Bilal, and professional organizations advise doctors to approach the issue.
What Exactly Is a Colon Cleanse?
Colon cleanses come in a variety of forms. Colonic irrigation, also called colon hydrotherapy, involves inserting a tube into the rectum and flushing out the colon with a large amount of fluid. Enemas do the same but use a small amount of liquid, and some product instructions tell the user to “hold it” for a designated amount of time before expelling colon contents.
Other cleanses, often called detoxing cleanses, are laxatives or herbal teas that users drink — and then stay close to the bathroom. Detox regimens and diets also are mentioned as a way to remove toxins from the body, improve health, and promote well-being.
Why Do Patients Use Them?
“Many patients describe a desire for ‘cleanliness,’ ‘detoxification,’ or to ‘feel lighter,’” Ali told GI & Hepatology News.
The claims on social media promote all of this and more — and well-known influencers make it all sound even more attractive.
“These motivations are often rooted in the cultural belief that the colon accumulates harmful toxins that must be flushed out,” Ali said. “This idea is not supported by scientific evidence. The body’s natural detox systems, primarily the liver and kidneys, already perform this function effectively.”
Bilal said that in recent years, he has noticed more awareness in general about the importance of gut health. “When there’s awareness, people often go to the other extreme,” he said.
Where Is the Evidence?
The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, warns on an information page that both cleansing and detox programs can be unsafe and falsely advertised.
While searches of medical literature turn up few studies, the NCCIH information points to a 2014 review that concluded that there is no compelling research to support the use of detox diets for managing weight or eliminating toxins. A 2017 review found juicing and detox regimens can cause weight loss initially but then lead to weight gain once a normal diet is resumed.
A systematic review of research on the safety and effectiveness of self-administered coffee enemas found nine case reports describing adverse events: seven reported colitis after the enema, and two reported more critical adverse events. All nine reports warned against the procedure. The researchers found no study reporting the effectiveness of coffee enemas.
The NCCIH information also notes that there is “limited clinical evidence validating colonic irrigation and insufficient evidence for its prescribed uses.”
Are Cleanses Regulated?
Some over-the-counter colon cleansing products are viewed as dietary supplements, giving the FDA authority to regulate them and take action under the Dietary Supplement Health and Education Act of 1994.
Certain products promoted as colon cleanses, such as laxatives, are regulated by the FDA as over-the-counter drugs and must meet safety and other requirements.
Colonic irrigation systems meant for cleansing before radiologic or endoscopic exams are class II devices — subject to 510(k) premarket notification requirements before marketing — whereas systems intended for other uses, such as routine colon cleansing for general well-being, are regarded as class III devices — subject to premarket approval requirements — according to an FDA spokesperson. To date, the FDA has not approved any colonic irrigation devices for the latter use, the spokesperson said.
For instance, the FDA warned consumers not to use a product promoted for colon cleansing after finding it contained tadalafil, the active ingredient in an FDA-approved drug for erectile dysfunction. The FDA has also issued numerous warning letters to the makers of colon cleansing devices, as they are not approved for this purpose.
The Federal Trade Commission can also take action specifically if the claims about the benefits and safety of products — including supplements, foods, over-the-counter drugs, or health equipment — are false, misleading, or not supported by science.
What Are the Dangers?
Cleanse and detox products come with many risks, including electrolyte imbalances, dehydration, and infections, Ali said. With colonic irrigation, there is a risk for rectal perforation. Products also may disrupt the gut microbiome, and some can interact with medications or worsen underlying health conditions, he added.
“It’s important for patients to be aware of these risks before considering nonmedical ‘cleaning’ methods,” he said.
At worst, patients risk fatality, Ali noted. He recalled a young patient who began using a vegetable enema as a detox. As it was being administered, the colon ruptured. The patient was admitted as a medical emergency and required surgery. Fortunately, the patient survived, but the incident could have proven fatal, Ali said.
Educating Patients
Because patients often don’t think of herbal cleanses, detox teas, and over-the-counter powders as supplements, Ali said it’s important to ask them about everything they take.
One way to frame this question is to ask if they are consuming any over-the-counter supplements or any other remedies, he said, and perhaps ask directly about any cleanses they are doing.
When patients ask him about colon cleanses, Ali explains the difference between evidence-based colonoscopy preparation and unregulated “cleanses.” Most patients respond to that approach, he said. Indeed, AGA and other GI societies updated their recommendations on optimizing bowel preparation quality for colonoscopy.
“Still, the appeal of quick fixes of social media trends can sometimes outweigh medical advice,” Ali said. He depends on building trusted relationships and reinforcing the message over time and finds that helps patients make informed and healthier choices.
Bilal, too, explains to patients that cleanses are unnecessary and educates them about what to do instead:
- Eat a containing the recommended amount of (22-34 g, depending on age and gender).
- For , follow a bowel regimen advised by your doctor.
- If gastrointestinal issues persist, get a medical checkup.
- Get any unexplained constipation or checked out by a doctor.
Taking a careful history can pay off, Ali has found. He questioned a patient complaining of abdominal discomfort whose testing found unexpectedly elevated liver enzymes and found she had been using an herbal “cleanse tea” found online. Within 4 weeks of stopping it, her liver enzymes normalized. “Thankfully, she made a full recovery — and she never touched those remedies again,” he said.
Ali had no relevant disclosures. Bilal reported consulting for Boston Scientific, Cook Medical, and Steris.
A version of this article appeared on Medscape.com.
Finding the Best Match for MASLD Management
, according to the authors of clinical reviews who offered guidance on the pros and cons of resmetirom and semaglutide.
MASLD has become one of the most common causes of chronic liver disease due to the increased prevalence of diabetes, obesity, and other metabolic disorders, Joanne Lin, DO, an internist in the Division of Gastroenterology and Hepatology at the University of California, San Francisco, and colleagues wrote, in a review published in the Journal of Clinical Gastroenterology.
Its complexity makes MASLD challenging to manage. Metabolic, genetic, and environmental factors are involved in the disease, so patients require multidisciplinary and individualized care, Lin told GI & Hepatology News.
Weight loss, dietary changes, and exercise had long been the only treatment approach clinicians could offer patients. But the approval of two drugs — the thyroid hormone receptor-beta agonist resmetirom and the GLP-1 receptor agonist (RA) semaglutide — for patients whose MASLD has advanced to metabolic dysfunction-associated steatohepatitis (MASH) gives physicians new options for patients with severe disease.
In the review, published online before the official approval of semaglutide, Lin and colleagues proposed an algorithm to guide clinicians in choosing a pharmacological therapy for MASLD. “Resmetirom should be primarily used to reverse fibrosis for patients with MASLD and F2-F3 stages, while GLP-1 RAs are beneficial in managing metabolic comorbidities and weight loss in patients with MASLD,” the researchers concluded.
GLP-1 Power and Potential
In August 2025, the FDA approved semaglutide for MASH and cited evidence from the ESSENCE trial in its decision.
The ESSENCE study, published in The New England Journal of Medicine, showed significantly higher rates of resolution of steatohepatitis without worsening of fibrosis and reduction in liver fibrosis without worsening steatohepatitis in patients with MASH and moderate or advanced liver fibrosis who received 2.4 mg of once-weekly semaglutide compared with patients who received placebo.
The most common adverse events reported with GLP-1 RAs are gastrointestinal-related, including nausea, diarrhea, vomiting, and constipation, and are mainly mild-to-moderate and dose dependent, Lin and colleagues noted in their review.
GLP-1s have some limitations, Lin said. “GLP-1s are great for weight loss and metabolic risk reduction, but studies are still ongoing to determine their effect on liver histology and reversing fibrosis/cirrhosis,” she said. Some patients seeking these medications also have trouble obtaining them because of their popularity for weight loss, she noted.
Resmetirom Shows Success
Resmetirom has demonstrated ability to target hepatocytes and increase the hepatic metabolism of lipids, Lin and colleagues wrote in their review.
Several trials have examined resmetirom as a treatment for MASH, notably the landmark MAESTRO-NASH study , a randomized, placebo-controlled trial of nearly 1000 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis, which was the basis for the FDA’s approval of the drug in 2024. In the study, 25.9% of the patients treated with 80 mg of resmetirom and 29.9% treated with 100 mg resmetirom achieved MASH resolution with no increase in fibrosis compared with 9.7% of patients treated with placebo. In addition, 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group achieved fibrosis improvement by at least one stage without worsening of MASLD activity scores compared with 14.2% of patients treated with placebo.
The most common reported side effects from resmetirom are diarrhea or constipation, nausea or vomiting, and abdominal pain.
“The limitations of resmetirom include the absence of validated predictors for individual patient response, and no societal guidelines are available to determine when to stop the medication if ineffective,” Lin told GI & Hepatology News. In addition, resmetirom is currently only recommended for a subset of patients with F2-F3 fibrosis, based on the existing trial, she said.
Other limitations include its high cost, which restricts access to the drug for some patients, and lack of long-term safety and efficacy data, Lin added.
Weighing the Options
Comparing the emerging agents in the context of MASLD/MASH is important to help clinicians understand how different patient populations respond and guide evidence-based treatment decisions, said Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, in an interview.
“The choice of therapy should be individualized based on comorbidities,” said Ayesh, the lead author of a 2024 review published in Biomedicines that compared resmetirom, GLP-1 agonists, and fibroblast growth factor 21 analogs.
“For example, a GLP-1 receptor agonist may be more appropriate for patients with coexisting diabetes or obesity, while resmetirom may be better suited for patients with more advanced liver disease or minimal metabolic comorbidities,” he said.
GLP-1 RAs, such as semaglutide, offer benefits for diabetes, obesity, and metabolic dysfunction in patients with MASLD/MASH and may be more accessible and cost effective, Ayesh told GI & Hepatology News. However, some patients may experience gastrointestinal side effects or be unable to tolerate GLP-1 RAs, he noted.
By contrast, resmetirom may be preferable for patients with low BMI, advanced fibrosis, or an inability to tolerate GLP-1s, as resmetirom directly targets hepatic pathways involved in MASLD/MASH progression, Ayesh said.
Next Steps to Inform Practice
“More research is needed to validate noninvasive biomarkers to monitor response to these medications, determine predictors of efficacy, and evaluate the additive effects, safety, and drug-drug interactions of combination therapy,” Lin said.
Studies are needed to determine both medications’ effects on patients with advanced fibrosis/cirrhosis and special populations, such as individuals with advanced renal disease or posttransplant patients, she added. More studies are expected to inform clinical practice and proper guidelines for the treatment of MASLD, as has been the case with chronic diseases such as hypertension and diabetes, Lin said.
Long-term safety and efficacy data are critical, as most trials of the newly approved medications have had relatively short follow-up periods of approximately 1 year, Ayesh said. “We need real-world evidence and longitudinal studies spanning 3-5 years to confirm sustained efficacy and safety,” he said. Research on cost effectiveness and health-system impacts will be essential to guide policy and ensure equitable access to the medications, he added.
The study by Lin and colleagues received no outside funding. The researchers had no financial conflicts to disclose. Ayesh had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, according to the authors of clinical reviews who offered guidance on the pros and cons of resmetirom and semaglutide.
MASLD has become one of the most common causes of chronic liver disease due to the increased prevalence of diabetes, obesity, and other metabolic disorders, Joanne Lin, DO, an internist in the Division of Gastroenterology and Hepatology at the University of California, San Francisco, and colleagues wrote, in a review published in the Journal of Clinical Gastroenterology.
Its complexity makes MASLD challenging to manage. Metabolic, genetic, and environmental factors are involved in the disease, so patients require multidisciplinary and individualized care, Lin told GI & Hepatology News.
Weight loss, dietary changes, and exercise had long been the only treatment approach clinicians could offer patients. But the approval of two drugs — the thyroid hormone receptor-beta agonist resmetirom and the GLP-1 receptor agonist (RA) semaglutide — for patients whose MASLD has advanced to metabolic dysfunction-associated steatohepatitis (MASH) gives physicians new options for patients with severe disease.
In the review, published online before the official approval of semaglutide, Lin and colleagues proposed an algorithm to guide clinicians in choosing a pharmacological therapy for MASLD. “Resmetirom should be primarily used to reverse fibrosis for patients with MASLD and F2-F3 stages, while GLP-1 RAs are beneficial in managing metabolic comorbidities and weight loss in patients with MASLD,” the researchers concluded.
GLP-1 Power and Potential
In August 2025, the FDA approved semaglutide for MASH and cited evidence from the ESSENCE trial in its decision.
The ESSENCE study, published in The New England Journal of Medicine, showed significantly higher rates of resolution of steatohepatitis without worsening of fibrosis and reduction in liver fibrosis without worsening steatohepatitis in patients with MASH and moderate or advanced liver fibrosis who received 2.4 mg of once-weekly semaglutide compared with patients who received placebo.
The most common adverse events reported with GLP-1 RAs are gastrointestinal-related, including nausea, diarrhea, vomiting, and constipation, and are mainly mild-to-moderate and dose dependent, Lin and colleagues noted in their review.
GLP-1s have some limitations, Lin said. “GLP-1s are great for weight loss and metabolic risk reduction, but studies are still ongoing to determine their effect on liver histology and reversing fibrosis/cirrhosis,” she said. Some patients seeking these medications also have trouble obtaining them because of their popularity for weight loss, she noted.
Resmetirom Shows Success
Resmetirom has demonstrated ability to target hepatocytes and increase the hepatic metabolism of lipids, Lin and colleagues wrote in their review.
Several trials have examined resmetirom as a treatment for MASH, notably the landmark MAESTRO-NASH study , a randomized, placebo-controlled trial of nearly 1000 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis, which was the basis for the FDA’s approval of the drug in 2024. In the study, 25.9% of the patients treated with 80 mg of resmetirom and 29.9% treated with 100 mg resmetirom achieved MASH resolution with no increase in fibrosis compared with 9.7% of patients treated with placebo. In addition, 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group achieved fibrosis improvement by at least one stage without worsening of MASLD activity scores compared with 14.2% of patients treated with placebo.
The most common reported side effects from resmetirom are diarrhea or constipation, nausea or vomiting, and abdominal pain.
“The limitations of resmetirom include the absence of validated predictors for individual patient response, and no societal guidelines are available to determine when to stop the medication if ineffective,” Lin told GI & Hepatology News. In addition, resmetirom is currently only recommended for a subset of patients with F2-F3 fibrosis, based on the existing trial, she said.
Other limitations include its high cost, which restricts access to the drug for some patients, and lack of long-term safety and efficacy data, Lin added.
Weighing the Options
Comparing the emerging agents in the context of MASLD/MASH is important to help clinicians understand how different patient populations respond and guide evidence-based treatment decisions, said Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, in an interview.
“The choice of therapy should be individualized based on comorbidities,” said Ayesh, the lead author of a 2024 review published in Biomedicines that compared resmetirom, GLP-1 agonists, and fibroblast growth factor 21 analogs.
“For example, a GLP-1 receptor agonist may be more appropriate for patients with coexisting diabetes or obesity, while resmetirom may be better suited for patients with more advanced liver disease or minimal metabolic comorbidities,” he said.
GLP-1 RAs, such as semaglutide, offer benefits for diabetes, obesity, and metabolic dysfunction in patients with MASLD/MASH and may be more accessible and cost effective, Ayesh told GI & Hepatology News. However, some patients may experience gastrointestinal side effects or be unable to tolerate GLP-1 RAs, he noted.
By contrast, resmetirom may be preferable for patients with low BMI, advanced fibrosis, or an inability to tolerate GLP-1s, as resmetirom directly targets hepatic pathways involved in MASLD/MASH progression, Ayesh said.
Next Steps to Inform Practice
“More research is needed to validate noninvasive biomarkers to monitor response to these medications, determine predictors of efficacy, and evaluate the additive effects, safety, and drug-drug interactions of combination therapy,” Lin said.
Studies are needed to determine both medications’ effects on patients with advanced fibrosis/cirrhosis and special populations, such as individuals with advanced renal disease or posttransplant patients, she added. More studies are expected to inform clinical practice and proper guidelines for the treatment of MASLD, as has been the case with chronic diseases such as hypertension and diabetes, Lin said.
Long-term safety and efficacy data are critical, as most trials of the newly approved medications have had relatively short follow-up periods of approximately 1 year, Ayesh said. “We need real-world evidence and longitudinal studies spanning 3-5 years to confirm sustained efficacy and safety,” he said. Research on cost effectiveness and health-system impacts will be essential to guide policy and ensure equitable access to the medications, he added.
The study by Lin and colleagues received no outside funding. The researchers had no financial conflicts to disclose. Ayesh had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, according to the authors of clinical reviews who offered guidance on the pros and cons of resmetirom and semaglutide.
MASLD has become one of the most common causes of chronic liver disease due to the increased prevalence of diabetes, obesity, and other metabolic disorders, Joanne Lin, DO, an internist in the Division of Gastroenterology and Hepatology at the University of California, San Francisco, and colleagues wrote, in a review published in the Journal of Clinical Gastroenterology.
Its complexity makes MASLD challenging to manage. Metabolic, genetic, and environmental factors are involved in the disease, so patients require multidisciplinary and individualized care, Lin told GI & Hepatology News.
Weight loss, dietary changes, and exercise had long been the only treatment approach clinicians could offer patients. But the approval of two drugs — the thyroid hormone receptor-beta agonist resmetirom and the GLP-1 receptor agonist (RA) semaglutide — for patients whose MASLD has advanced to metabolic dysfunction-associated steatohepatitis (MASH) gives physicians new options for patients with severe disease.
In the review, published online before the official approval of semaglutide, Lin and colleagues proposed an algorithm to guide clinicians in choosing a pharmacological therapy for MASLD. “Resmetirom should be primarily used to reverse fibrosis for patients with MASLD and F2-F3 stages, while GLP-1 RAs are beneficial in managing metabolic comorbidities and weight loss in patients with MASLD,” the researchers concluded.
GLP-1 Power and Potential
In August 2025, the FDA approved semaglutide for MASH and cited evidence from the ESSENCE trial in its decision.
The ESSENCE study, published in The New England Journal of Medicine, showed significantly higher rates of resolution of steatohepatitis without worsening of fibrosis and reduction in liver fibrosis without worsening steatohepatitis in patients with MASH and moderate or advanced liver fibrosis who received 2.4 mg of once-weekly semaglutide compared with patients who received placebo.
The most common adverse events reported with GLP-1 RAs are gastrointestinal-related, including nausea, diarrhea, vomiting, and constipation, and are mainly mild-to-moderate and dose dependent, Lin and colleagues noted in their review.
GLP-1s have some limitations, Lin said. “GLP-1s are great for weight loss and metabolic risk reduction, but studies are still ongoing to determine their effect on liver histology and reversing fibrosis/cirrhosis,” she said. Some patients seeking these medications also have trouble obtaining them because of their popularity for weight loss, she noted.
Resmetirom Shows Success
Resmetirom has demonstrated ability to target hepatocytes and increase the hepatic metabolism of lipids, Lin and colleagues wrote in their review.
Several trials have examined resmetirom as a treatment for MASH, notably the landmark MAESTRO-NASH study , a randomized, placebo-controlled trial of nearly 1000 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis, which was the basis for the FDA’s approval of the drug in 2024. In the study, 25.9% of the patients treated with 80 mg of resmetirom and 29.9% treated with 100 mg resmetirom achieved MASH resolution with no increase in fibrosis compared with 9.7% of patients treated with placebo. In addition, 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group achieved fibrosis improvement by at least one stage without worsening of MASLD activity scores compared with 14.2% of patients treated with placebo.
The most common reported side effects from resmetirom are diarrhea or constipation, nausea or vomiting, and abdominal pain.
“The limitations of resmetirom include the absence of validated predictors for individual patient response, and no societal guidelines are available to determine when to stop the medication if ineffective,” Lin told GI & Hepatology News. In addition, resmetirom is currently only recommended for a subset of patients with F2-F3 fibrosis, based on the existing trial, she said.
Other limitations include its high cost, which restricts access to the drug for some patients, and lack of long-term safety and efficacy data, Lin added.
Weighing the Options
Comparing the emerging agents in the context of MASLD/MASH is important to help clinicians understand how different patient populations respond and guide evidence-based treatment decisions, said Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, in an interview.
“The choice of therapy should be individualized based on comorbidities,” said Ayesh, the lead author of a 2024 review published in Biomedicines that compared resmetirom, GLP-1 agonists, and fibroblast growth factor 21 analogs.
“For example, a GLP-1 receptor agonist may be more appropriate for patients with coexisting diabetes or obesity, while resmetirom may be better suited for patients with more advanced liver disease or minimal metabolic comorbidities,” he said.
GLP-1 RAs, such as semaglutide, offer benefits for diabetes, obesity, and metabolic dysfunction in patients with MASLD/MASH and may be more accessible and cost effective, Ayesh told GI & Hepatology News. However, some patients may experience gastrointestinal side effects or be unable to tolerate GLP-1 RAs, he noted.
By contrast, resmetirom may be preferable for patients with low BMI, advanced fibrosis, or an inability to tolerate GLP-1s, as resmetirom directly targets hepatic pathways involved in MASLD/MASH progression, Ayesh said.
Next Steps to Inform Practice
“More research is needed to validate noninvasive biomarkers to monitor response to these medications, determine predictors of efficacy, and evaluate the additive effects, safety, and drug-drug interactions of combination therapy,” Lin said.
Studies are needed to determine both medications’ effects on patients with advanced fibrosis/cirrhosis and special populations, such as individuals with advanced renal disease or posttransplant patients, she added. More studies are expected to inform clinical practice and proper guidelines for the treatment of MASLD, as has been the case with chronic diseases such as hypertension and diabetes, Lin said.
Long-term safety and efficacy data are critical, as most trials of the newly approved medications have had relatively short follow-up periods of approximately 1 year, Ayesh said. “We need real-world evidence and longitudinal studies spanning 3-5 years to confirm sustained efficacy and safety,” he said. Research on cost effectiveness and health-system impacts will be essential to guide policy and ensure equitable access to the medications, he added.
The study by Lin and colleagues received no outside funding. The researchers had no financial conflicts to disclose. Ayesh had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Half of Patients Skip Repeat Stool Tests for CRC Screening
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
Anti-TNF Exposure Influences Efficacy of Subsequent Therapies in UC
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
, based on results of a large meta-analysis.
Patients previously treated with TNF antagonists were less likely to respond to lymphocyte trafficking inhibitors but more likely to achieve remission on Janus kinase (JAK) inhibitors, Han Hee Lee, MD, PhD, of the University of California San Diego, and colleagues reported.
“Treatment options for patients with moderate-severe ulcerative colitis have increased in the last decade with the availability of six different classes of medications,” investigators wrote in Clinical Gastroenterology and Hepatology (2024 Dec. doi:10.1016/j.cgh.2024.12.007). “There is wide interindividual variability in response to specific medications, and drivers of this heterogeneity are critical to understand to be able to choose the best therapy for each individual patient.”
To learn more about the impacts of anti-TNF exposure on subsequent advanced therapies, the investigators conducted a systematic review and meta-analysis of 17 phase 2 and 3 trials. The dataset included 8,871 adults with moderate-severe UC.
The primary outcome was induction of clinical remission at 6–14 weeks, most often defined as a Mayo Clinic score of 2 or lower with no subscore greater than 1. Endoscopic improvement, generally defined as a Mayo endoscopic subscore of 0 or 1, was evaluated as a secondary endpoint.
Advanced therapies were grouped by mechanism of action, including lymphocyte trafficking inhibitors, JAK inhibitors, and interleukin (IL)-12/23 and IL-23 antagonists. Odds ratios for treatment versus placebo were calculated separately for each subgroup, and a ratio of odds ratios was then used to assess whether prior TNF exposure modified drug effect. Analyses were conducted on an intention-to-treat basis, restricted to approved dosing when multiple regimens were tested.
Across five trials of lymphocyte trafficking inhibitors including 2,046 patients, efficacy was significantly greater in TNF-naïve patients compared with those who had prior TNF exposure. The odds of achieving clinical remission were nearly doubled in the TNF-naïve group (ratio of odds ratios [ROR], 1.88; 95% CI, 1.02–3.49).
In six trials of JAK inhibitors including 3,015 patients, remission rates were higher among TNF-exposed patients com-pared with TNF-naïve patients (ROR, 0.47; 95% CI, 0.22–1.01).
In six trials of IL-12/23 and IL-23 antagonists, including 3,810 patients, prior TNF exposure did not significantly modify treatment outcomes (ROR, 1.07; 95% CI, 0.64–1.80). Within individual trials, ustekinumab showed a trend toward great-er efficacy in TNF-exposed patients, whereas selective IL-23 antagonists performed similarly regardless of TNF exposure history.
Secondary analyses of endoscopic improvement yielded results consistent with the primary endpoint. Statistical heterogeneity across trials was minimal, and all included studies were rated at low risk of bias.
The investigators noted several limitations. For example, therapies were grouped broadly by mechanism of action, although specific biologic effects could potentially differ within groups. The analysis also could not account for patients who had failed two or more classes of advanced therapy, which may independently reduce the likelihood of response.
Still, Lee and colleagues suggested that the findings deserve a closer look.
“[T]here is significant heterogeneity of treatment efficacy for induction of remission with different advanced therapies in patients with moderate-severe UC based on prior exposure to TNF antagonists,” they concluded. “Future studies on the mechanistic insight for these intriguing observations are warranted.”
The study was supported by the Leona and Harry B. Helmsley Trust, the National Institutes of Health, and the Centers for Disease Control and Prevention. The investigators disclosed relationships with AbbVie, Ferring, Pfizer, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Making Surgery Safer for Patients With Cirrhosis
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
, according to an updated guideline from the American College of Gastroenterology.
Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology.
“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.
“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.
The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.
Three conditional recommendations:
- For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
- For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
- For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.
The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis.
What’s New and Notable?
New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.
The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.
Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.
“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.
These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.
Tackling Clinical Challenges
The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.
“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.
“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.
For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.
The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose.
A version of this article appeared on Medscape.com
‘At-Need’ Endoscopy Equal to Standard Surveillance in Barrett’s Patients?
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
FROM GASTROENTEROLOGY
MASLD/MASH Global Consensus Recommendations Address Guideline Discordance
These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.
“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”
To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.
Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.
The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”
For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.
Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.
Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.
The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.
Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.
“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.
The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.
The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.
Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”
He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes.
“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.
Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.”
He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”
“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.
Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.
The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.
Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”
He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes.
“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.
Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.”
He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”
“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.
Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.
The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.
Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”
He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes.
“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.
Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.”
He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”
“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.
Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.
These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.
“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”
To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.
Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.
The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”
For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.
Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.
Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.
The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.
Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.
“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.
The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.
These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.
“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”
To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.
Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.
The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”
For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.
Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.
Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.
The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.
Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.
“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.
The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.
FROM GASTROENTEROLOGY
Long-Term Data Support Reduced-Dose Maintenance in EoE
, according to a recent meta-analysis of long-term data.
These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.
“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”
In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.
The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.
Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.
Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.
Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.
In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.
Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).
Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.
“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.
The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
, according to a recent meta-analysis of long-term data.
These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.
“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”
In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.
The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.
Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.
Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.
Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.
In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.
Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).
Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.
“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.
The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
, according to a recent meta-analysis of long-term data.
These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.
“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”
In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.
The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.
Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.
Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.
Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.
In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.
Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).
Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.
“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.
The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
FROM GASTROENTEROLOGY
Simpler Approach Increases Diagnostic Accuracy of Timed Barium Esophagram for Achalasia
, according to investigators.
The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.
“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”
TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.
To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.
Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.
Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.
The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.
Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.
The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.
“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”
Clinical Takeaways
Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.
“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”
Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.
“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”
Implementation, however, requires discipline.
“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”
Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.
“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.
This study was supported by the Public Health Service.
The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.
A version of this article appeared on Medscape.com.
, according to investigators.
The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.
“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”
TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.
To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.
Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.
Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.
The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.
Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.
The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.
“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”
Clinical Takeaways
Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.
“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”
Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.
“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”
Implementation, however, requires discipline.
“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”
Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.
“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.
This study was supported by the Public Health Service.
The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.
A version of this article appeared on Medscape.com.
, according to investigators.
The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.
“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”
TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.
To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.
Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.
Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.
The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.
Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.
The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.
“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”
Clinical Takeaways
Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.
“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”
Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.
“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”
Implementation, however, requires discipline.
“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”
Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.
“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.
This study was supported by the Public Health Service.
The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY