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Pediatric Wilson’s Disease Carries Higher Risk of Worse Outcomes
, according to data from a large single-center study in India.
These findings underscore the importance of early recognition and genetic evaluation in pediatric patients, and timely consideration of liver transplantation in severe presentations, reported lead author Anand V. Kulkarni, MD, of AIG Hospitals, Hyderabad, India, and colleagues.
“There is a lack of large cohort studies evaluating the clinical presentation of WD, along with a limited understanding of genotype–phenotype correlations in patients with WD presenting with liver disease and the absence of comprehensive comparisons between pediatric and adult outcomes,” the investigators wrote in Gastro Hep Advances (2025 Jun. doi: 10.1016/j.gastha.2025.100717). “Additionally, data on living donor liver transplantation (LDLT) outcomes in WD remain scarce.”
To address these gaps, Kulkarni and colleagues performed a single-center retrospective study of all patients with WD diagnosed and managed at AIG Hospitals between June 2020 and April 2024.
Diagnosis followed Leipzig criteria, incorporating clinical features, slit-lamp examination for Kayser–Fleischer rings, serum ceruloplasmin, 24-hour urinary copper, hepatic copper when available, and genetic testing when available.
Patients were stratified by age into pediatric and adult groups. The investigators compared clinical presentation, laboratory parameters, and outcomes across age groups.
Management reflected standard practice at the center: chelation with D-penicillamine or trientine, zinc therapy as monotherapy or adjunctive therapy, plasma exchange for acute liver failure or acute-on-chronic liver failure, and evaluation for living-donor liver transplantation when indicated. Genetic analysis was performed in approximately 70% of the cohort.
The final dataset included 156 patients, with a median age of 19 years (range, 2–57), and an approximately equal split between adult and pediatric groups.
Presentation differed markedly by age. Among pediatric patients, the most common presentations were acute liver failure (26.7%) and acute-on-chronic liver failure (20%). Adults most frequently presented with decompensated cirrhosis (30.9%). Kayser–Fleischer rings were more prevalent in the pediatric group, consistent with underlying disease despite acute presentation.
Outcomes also varied by age and presentation. On Kaplan–Meier analysis, transplant-free survival was 72% in children and 87.7% in adults after a median follow-up of 1.33 years (P = .01). Overall cohort transplant-free survival at 1.33 years was 80.1%. Thirteen percent of patients underwent LDLT, with 90% 1-year post-transplant survival. Among those who received plasma exchange for acute presentations, transplant-free survival was 40.5%.
Among the patients with genetic data, 54.1% were homozygous or compound heterozygous for combinations of pathogenic variants and variants of uncertain significance in ATP7B. The most frequently observed pathogenic variants were p.Gly977Glu, p.Cys271Ter, and p.Asn1186Ser. Several additional variants, including novel changes, were identified across the cohort.
No consistent genotype–phenotype correlation was observed. The investigators noted that the center’s focus on liver disease likely enriched the cohort for hepatic presentations, and that some patients were included based on Leipzig scores of 2-3 with supportive clinical response to therapy.
“Further research should focus on identifying structural variants, variants in other genes, and epigenetic modulators of genetic expression,” Kulkarni and colleagues concluded.
The genetic tests were performed with intramural funding support from the Asian Healthcare Foundation, provided to AIG Hospitals Hyderabad. The investigators disclosed no conflicts of interest.
Wilson’s disease (WD), initially described in 1912 by Dr. Kinnier Wilson, continues to pose a significant challenge to clinicians over a century later. This autosomal recessive disorder is characterized by mutations in ATP7B gene, which impair the body’s capacity to transport and eliminate copper effectively. Although classified as rare, WD has a notable clinical impact. It is estimated to affect approximately 1 in every 30,000 individuals globally. Given the disease’s highly variable presentation, many individuals likely remain undiagnosed or misdiagnosed, and the consequences of delayed treatment are substantial.
The presented study by Kulkarni and colleagues offers a valuable contribution to the understanding of WD, particularly emphasizing the major clinical differences between pediatric and adult patients, and the implications of these differences for management and survival. As the authors note, transplant-free survival was significantly lower in children (72%) compared with adults (87.7%), reflecting the more aggressive natural history at younger ages. This reinforces the need for earlier detection and prompt initiation of chelation therapy when WD is suspected. Another observation is poor transplant-free survival among patients with acute liver failure with plasma exchange (40.5%), which highlights its role may be as a bridge to liver transplant. The genetic analysis is particularly interesting. Although over half of patients carried homozygous or compound heterozygous ATP7B variants, there was no clear genotype–phenotype correlation. This aligns with prior WD literature.
The investigators acknowledge limitations like the center’s focus on liver disease likely selected for hepatically severe WD, and the retrospective design limits completeness of data. Nevertheless, its strengths lie in the relatively large single-center cohort, use of standardized diagnostic criteria, and detailed genetic analysis in 70% of cases. The study reinforces several practical takeaways. Children require heightened vigilance, as their disease often presents suddenly, and timely referral for transplant evaluation is critical in ALF presentations. Long-term survival hinges on early detection and consistent chelation therapy.
Hrishikesh Samant, MD, is medical director, hepatology, at Ochsner Medical Center, Baton Rouge, Louisiana, and associate professor of gastroenterology, LSU Health and Xavier Ochsner College of Medicine, New Orleans. He declared no conflicts of interest.
Wilson’s disease (WD), initially described in 1912 by Dr. Kinnier Wilson, continues to pose a significant challenge to clinicians over a century later. This autosomal recessive disorder is characterized by mutations in ATP7B gene, which impair the body’s capacity to transport and eliminate copper effectively. Although classified as rare, WD has a notable clinical impact. It is estimated to affect approximately 1 in every 30,000 individuals globally. Given the disease’s highly variable presentation, many individuals likely remain undiagnosed or misdiagnosed, and the consequences of delayed treatment are substantial.
The presented study by Kulkarni and colleagues offers a valuable contribution to the understanding of WD, particularly emphasizing the major clinical differences between pediatric and adult patients, and the implications of these differences for management and survival. As the authors note, transplant-free survival was significantly lower in children (72%) compared with adults (87.7%), reflecting the more aggressive natural history at younger ages. This reinforces the need for earlier detection and prompt initiation of chelation therapy when WD is suspected. Another observation is poor transplant-free survival among patients with acute liver failure with plasma exchange (40.5%), which highlights its role may be as a bridge to liver transplant. The genetic analysis is particularly interesting. Although over half of patients carried homozygous or compound heterozygous ATP7B variants, there was no clear genotype–phenotype correlation. This aligns with prior WD literature.
The investigators acknowledge limitations like the center’s focus on liver disease likely selected for hepatically severe WD, and the retrospective design limits completeness of data. Nevertheless, its strengths lie in the relatively large single-center cohort, use of standardized diagnostic criteria, and detailed genetic analysis in 70% of cases. The study reinforces several practical takeaways. Children require heightened vigilance, as their disease often presents suddenly, and timely referral for transplant evaluation is critical in ALF presentations. Long-term survival hinges on early detection and consistent chelation therapy.
Hrishikesh Samant, MD, is medical director, hepatology, at Ochsner Medical Center, Baton Rouge, Louisiana, and associate professor of gastroenterology, LSU Health and Xavier Ochsner College of Medicine, New Orleans. He declared no conflicts of interest.
Wilson’s disease (WD), initially described in 1912 by Dr. Kinnier Wilson, continues to pose a significant challenge to clinicians over a century later. This autosomal recessive disorder is characterized by mutations in ATP7B gene, which impair the body’s capacity to transport and eliminate copper effectively. Although classified as rare, WD has a notable clinical impact. It is estimated to affect approximately 1 in every 30,000 individuals globally. Given the disease’s highly variable presentation, many individuals likely remain undiagnosed or misdiagnosed, and the consequences of delayed treatment are substantial.
The presented study by Kulkarni and colleagues offers a valuable contribution to the understanding of WD, particularly emphasizing the major clinical differences between pediatric and adult patients, and the implications of these differences for management and survival. As the authors note, transplant-free survival was significantly lower in children (72%) compared with adults (87.7%), reflecting the more aggressive natural history at younger ages. This reinforces the need for earlier detection and prompt initiation of chelation therapy when WD is suspected. Another observation is poor transplant-free survival among patients with acute liver failure with plasma exchange (40.5%), which highlights its role may be as a bridge to liver transplant. The genetic analysis is particularly interesting. Although over half of patients carried homozygous or compound heterozygous ATP7B variants, there was no clear genotype–phenotype correlation. This aligns with prior WD literature.
The investigators acknowledge limitations like the center’s focus on liver disease likely selected for hepatically severe WD, and the retrospective design limits completeness of data. Nevertheless, its strengths lie in the relatively large single-center cohort, use of standardized diagnostic criteria, and detailed genetic analysis in 70% of cases. The study reinforces several practical takeaways. Children require heightened vigilance, as their disease often presents suddenly, and timely referral for transplant evaluation is critical in ALF presentations. Long-term survival hinges on early detection and consistent chelation therapy.
Hrishikesh Samant, MD, is medical director, hepatology, at Ochsner Medical Center, Baton Rouge, Louisiana, and associate professor of gastroenterology, LSU Health and Xavier Ochsner College of Medicine, New Orleans. He declared no conflicts of interest.
, according to data from a large single-center study in India.
These findings underscore the importance of early recognition and genetic evaluation in pediatric patients, and timely consideration of liver transplantation in severe presentations, reported lead author Anand V. Kulkarni, MD, of AIG Hospitals, Hyderabad, India, and colleagues.
“There is a lack of large cohort studies evaluating the clinical presentation of WD, along with a limited understanding of genotype–phenotype correlations in patients with WD presenting with liver disease and the absence of comprehensive comparisons between pediatric and adult outcomes,” the investigators wrote in Gastro Hep Advances (2025 Jun. doi: 10.1016/j.gastha.2025.100717). “Additionally, data on living donor liver transplantation (LDLT) outcomes in WD remain scarce.”
To address these gaps, Kulkarni and colleagues performed a single-center retrospective study of all patients with WD diagnosed and managed at AIG Hospitals between June 2020 and April 2024.
Diagnosis followed Leipzig criteria, incorporating clinical features, slit-lamp examination for Kayser–Fleischer rings, serum ceruloplasmin, 24-hour urinary copper, hepatic copper when available, and genetic testing when available.
Patients were stratified by age into pediatric and adult groups. The investigators compared clinical presentation, laboratory parameters, and outcomes across age groups.
Management reflected standard practice at the center: chelation with D-penicillamine or trientine, zinc therapy as monotherapy or adjunctive therapy, plasma exchange for acute liver failure or acute-on-chronic liver failure, and evaluation for living-donor liver transplantation when indicated. Genetic analysis was performed in approximately 70% of the cohort.
The final dataset included 156 patients, with a median age of 19 years (range, 2–57), and an approximately equal split between adult and pediatric groups.
Presentation differed markedly by age. Among pediatric patients, the most common presentations were acute liver failure (26.7%) and acute-on-chronic liver failure (20%). Adults most frequently presented with decompensated cirrhosis (30.9%). Kayser–Fleischer rings were more prevalent in the pediatric group, consistent with underlying disease despite acute presentation.
Outcomes also varied by age and presentation. On Kaplan–Meier analysis, transplant-free survival was 72% in children and 87.7% in adults after a median follow-up of 1.33 years (P = .01). Overall cohort transplant-free survival at 1.33 years was 80.1%. Thirteen percent of patients underwent LDLT, with 90% 1-year post-transplant survival. Among those who received plasma exchange for acute presentations, transplant-free survival was 40.5%.
Among the patients with genetic data, 54.1% were homozygous or compound heterozygous for combinations of pathogenic variants and variants of uncertain significance in ATP7B. The most frequently observed pathogenic variants were p.Gly977Glu, p.Cys271Ter, and p.Asn1186Ser. Several additional variants, including novel changes, were identified across the cohort.
No consistent genotype–phenotype correlation was observed. The investigators noted that the center’s focus on liver disease likely enriched the cohort for hepatic presentations, and that some patients were included based on Leipzig scores of 2-3 with supportive clinical response to therapy.
“Further research should focus on identifying structural variants, variants in other genes, and epigenetic modulators of genetic expression,” Kulkarni and colleagues concluded.
The genetic tests were performed with intramural funding support from the Asian Healthcare Foundation, provided to AIG Hospitals Hyderabad. The investigators disclosed no conflicts of interest.
, according to data from a large single-center study in India.
These findings underscore the importance of early recognition and genetic evaluation in pediatric patients, and timely consideration of liver transplantation in severe presentations, reported lead author Anand V. Kulkarni, MD, of AIG Hospitals, Hyderabad, India, and colleagues.
“There is a lack of large cohort studies evaluating the clinical presentation of WD, along with a limited understanding of genotype–phenotype correlations in patients with WD presenting with liver disease and the absence of comprehensive comparisons between pediatric and adult outcomes,” the investigators wrote in Gastro Hep Advances (2025 Jun. doi: 10.1016/j.gastha.2025.100717). “Additionally, data on living donor liver transplantation (LDLT) outcomes in WD remain scarce.”
To address these gaps, Kulkarni and colleagues performed a single-center retrospective study of all patients with WD diagnosed and managed at AIG Hospitals between June 2020 and April 2024.
Diagnosis followed Leipzig criteria, incorporating clinical features, slit-lamp examination for Kayser–Fleischer rings, serum ceruloplasmin, 24-hour urinary copper, hepatic copper when available, and genetic testing when available.
Patients were stratified by age into pediatric and adult groups. The investigators compared clinical presentation, laboratory parameters, and outcomes across age groups.
Management reflected standard practice at the center: chelation with D-penicillamine or trientine, zinc therapy as monotherapy or adjunctive therapy, plasma exchange for acute liver failure or acute-on-chronic liver failure, and evaluation for living-donor liver transplantation when indicated. Genetic analysis was performed in approximately 70% of the cohort.
The final dataset included 156 patients, with a median age of 19 years (range, 2–57), and an approximately equal split between adult and pediatric groups.
Presentation differed markedly by age. Among pediatric patients, the most common presentations were acute liver failure (26.7%) and acute-on-chronic liver failure (20%). Adults most frequently presented with decompensated cirrhosis (30.9%). Kayser–Fleischer rings were more prevalent in the pediatric group, consistent with underlying disease despite acute presentation.
Outcomes also varied by age and presentation. On Kaplan–Meier analysis, transplant-free survival was 72% in children and 87.7% in adults after a median follow-up of 1.33 years (P = .01). Overall cohort transplant-free survival at 1.33 years was 80.1%. Thirteen percent of patients underwent LDLT, with 90% 1-year post-transplant survival. Among those who received plasma exchange for acute presentations, transplant-free survival was 40.5%.
Among the patients with genetic data, 54.1% were homozygous or compound heterozygous for combinations of pathogenic variants and variants of uncertain significance in ATP7B. The most frequently observed pathogenic variants were p.Gly977Glu, p.Cys271Ter, and p.Asn1186Ser. Several additional variants, including novel changes, were identified across the cohort.
No consistent genotype–phenotype correlation was observed. The investigators noted that the center’s focus on liver disease likely enriched the cohort for hepatic presentations, and that some patients were included based on Leipzig scores of 2-3 with supportive clinical response to therapy.
“Further research should focus on identifying structural variants, variants in other genes, and epigenetic modulators of genetic expression,” Kulkarni and colleagues concluded.
The genetic tests were performed with intramural funding support from the Asian Healthcare Foundation, provided to AIG Hospitals Hyderabad. The investigators disclosed no conflicts of interest.
FROM GASTRO HEP ADVANCES
GI Endoscopists Want More Training in Moderate Sedation
PHOENIX — , and a majority would be interested in providing physician-directed propofol sedation, especially after in-person or online training, according to results from an ongoing survey presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The dwindling supply of anesthesiology professionals in the US puts pressure on endoscopists, Dayna S. Early, MD, professor of medicine in the Gastroenterology Division at the Washington University, director of endoscopy at Barnes-Jewish Hospital, both in St. Louis, and chair of an ACG task force on anesthesia issues, told meeting attendees. However, preliminary results from the survey found that only about 4% of respondents said they used solely endoscopist-directed moderate sedation.
This could be because — as the survey also showed — GI fellows are not receiving adequate training in moderate sedation, which requires no interventions to maintain a patient airway, she reported. About 80% of program directors and 75% of senior fellows responding to the survey said they received training in moderate/conscious sedation during their fellowship.
These numbers are not impressive, said Early.
The Accreditation Council for Graduate Medical Education (ACGME) requires gastroenterology fellows to demonstrate competence in conscious sedation, along with other core skills, she explained. “What if I substituted training in mucosal biopsy or training in colonoscopy with polypectomy, which are other core requirements? I think you’d be shocked.”
The survey was small, with only 92 of 250 program directors and 33 of 655 fellows responding, but Early said the task force continues to collect responses.
Is Existing Training Enough?
Ten percent of fellows who replied to the survey did not participate in any moderate sedation procedures during training. And about a third of program directors said fellows participated in less than 100 such procedures.
“We really don’t know if that’s enough, in this era of competency-based assessment, which really values competency measures over numbers,” said Early.
Of the fellows who did receive training, 37% received hands-on training, a quarter received didactic lecture training, 11% used online modules, and 17% received a combination of the above training methods.
Just two thirds of program directors said they or their fellows were competent in moderate sedation, while close to 70% of fellows judged themselves competent.
While the majority of program directors (80%) knew that training in conscious sedation was a core ACGME requirement, only around a quarter of fellows were aware of the requirement.
Most gastroenterologists rely on anesthesiologists or certified registered nurse anesthetists (CRNAs) to deliver moderate or deep sedation, said Early, citing results from a separate survey sent to practicing clinicians.
Ongoing Shortages of CRNAs and Anesthesiologists
Shortages of anesthesiologists and CRNAs will continue to limit endoscopy procedure volume, especially in rural areas of the US, said Early.
The nation is expected to be short by 450,000 CRNAs this year and by 6300 anesthesiologists within a decade, she reported. Anesthesia providers are burned out or nearing retirement age, and there are not enough residency programs to produce new anesthesiologists at the rate needed to meet the demand, she said.
Gastroenterologists have become reliant on anesthesia providers, but adding a clinician is more expensive and “doesn’t appear to resolve and improve safety as compared with endoscopist-directed sedation for routine procedures,” said Early.
When practicing clinicians were asked if they’d be interested in providing physician-directed propofol sedation, 20% said yes, while 35% said no. But 16% said they would want to provide moderate sedation after completing in-person training, and 19% said they would after completing online training.
It may take time for gastroenterologists to get appropriate training and reduce reliance on anesthesia providers, Early said. But she said it may be increasingly possible in states allowing endoscopist-directed, nurse-administered propofol, and with medications such as remimazolam, a rapid-acting benzodiazepine that has shown similar efficacy and lower adverse event rates than propofol.
There will have to be a really deliberate step in order to take back control of endoscopic sedation from anesthesia and start performing more modest sedation, she said.
Early reported having no conflicts.
A version of this article first appeared on Medscape.com.
PHOENIX — , and a majority would be interested in providing physician-directed propofol sedation, especially after in-person or online training, according to results from an ongoing survey presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The dwindling supply of anesthesiology professionals in the US puts pressure on endoscopists, Dayna S. Early, MD, professor of medicine in the Gastroenterology Division at the Washington University, director of endoscopy at Barnes-Jewish Hospital, both in St. Louis, and chair of an ACG task force on anesthesia issues, told meeting attendees. However, preliminary results from the survey found that only about 4% of respondents said they used solely endoscopist-directed moderate sedation.
This could be because — as the survey also showed — GI fellows are not receiving adequate training in moderate sedation, which requires no interventions to maintain a patient airway, she reported. About 80% of program directors and 75% of senior fellows responding to the survey said they received training in moderate/conscious sedation during their fellowship.
These numbers are not impressive, said Early.
The Accreditation Council for Graduate Medical Education (ACGME) requires gastroenterology fellows to demonstrate competence in conscious sedation, along with other core skills, she explained. “What if I substituted training in mucosal biopsy or training in colonoscopy with polypectomy, which are other core requirements? I think you’d be shocked.”
The survey was small, with only 92 of 250 program directors and 33 of 655 fellows responding, but Early said the task force continues to collect responses.
Is Existing Training Enough?
Ten percent of fellows who replied to the survey did not participate in any moderate sedation procedures during training. And about a third of program directors said fellows participated in less than 100 such procedures.
“We really don’t know if that’s enough, in this era of competency-based assessment, which really values competency measures over numbers,” said Early.
Of the fellows who did receive training, 37% received hands-on training, a quarter received didactic lecture training, 11% used online modules, and 17% received a combination of the above training methods.
Just two thirds of program directors said they or their fellows were competent in moderate sedation, while close to 70% of fellows judged themselves competent.
While the majority of program directors (80%) knew that training in conscious sedation was a core ACGME requirement, only around a quarter of fellows were aware of the requirement.
Most gastroenterologists rely on anesthesiologists or certified registered nurse anesthetists (CRNAs) to deliver moderate or deep sedation, said Early, citing results from a separate survey sent to practicing clinicians.
Ongoing Shortages of CRNAs and Anesthesiologists
Shortages of anesthesiologists and CRNAs will continue to limit endoscopy procedure volume, especially in rural areas of the US, said Early.
The nation is expected to be short by 450,000 CRNAs this year and by 6300 anesthesiologists within a decade, she reported. Anesthesia providers are burned out or nearing retirement age, and there are not enough residency programs to produce new anesthesiologists at the rate needed to meet the demand, she said.
Gastroenterologists have become reliant on anesthesia providers, but adding a clinician is more expensive and “doesn’t appear to resolve and improve safety as compared with endoscopist-directed sedation for routine procedures,” said Early.
When practicing clinicians were asked if they’d be interested in providing physician-directed propofol sedation, 20% said yes, while 35% said no. But 16% said they would want to provide moderate sedation after completing in-person training, and 19% said they would after completing online training.
It may take time for gastroenterologists to get appropriate training and reduce reliance on anesthesia providers, Early said. But she said it may be increasingly possible in states allowing endoscopist-directed, nurse-administered propofol, and with medications such as remimazolam, a rapid-acting benzodiazepine that has shown similar efficacy and lower adverse event rates than propofol.
There will have to be a really deliberate step in order to take back control of endoscopic sedation from anesthesia and start performing more modest sedation, she said.
Early reported having no conflicts.
A version of this article first appeared on Medscape.com.
PHOENIX — , and a majority would be interested in providing physician-directed propofol sedation, especially after in-person or online training, according to results from an ongoing survey presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The dwindling supply of anesthesiology professionals in the US puts pressure on endoscopists, Dayna S. Early, MD, professor of medicine in the Gastroenterology Division at the Washington University, director of endoscopy at Barnes-Jewish Hospital, both in St. Louis, and chair of an ACG task force on anesthesia issues, told meeting attendees. However, preliminary results from the survey found that only about 4% of respondents said they used solely endoscopist-directed moderate sedation.
This could be because — as the survey also showed — GI fellows are not receiving adequate training in moderate sedation, which requires no interventions to maintain a patient airway, she reported. About 80% of program directors and 75% of senior fellows responding to the survey said they received training in moderate/conscious sedation during their fellowship.
These numbers are not impressive, said Early.
The Accreditation Council for Graduate Medical Education (ACGME) requires gastroenterology fellows to demonstrate competence in conscious sedation, along with other core skills, she explained. “What if I substituted training in mucosal biopsy or training in colonoscopy with polypectomy, which are other core requirements? I think you’d be shocked.”
The survey was small, with only 92 of 250 program directors and 33 of 655 fellows responding, but Early said the task force continues to collect responses.
Is Existing Training Enough?
Ten percent of fellows who replied to the survey did not participate in any moderate sedation procedures during training. And about a third of program directors said fellows participated in less than 100 such procedures.
“We really don’t know if that’s enough, in this era of competency-based assessment, which really values competency measures over numbers,” said Early.
Of the fellows who did receive training, 37% received hands-on training, a quarter received didactic lecture training, 11% used online modules, and 17% received a combination of the above training methods.
Just two thirds of program directors said they or their fellows were competent in moderate sedation, while close to 70% of fellows judged themselves competent.
While the majority of program directors (80%) knew that training in conscious sedation was a core ACGME requirement, only around a quarter of fellows were aware of the requirement.
Most gastroenterologists rely on anesthesiologists or certified registered nurse anesthetists (CRNAs) to deliver moderate or deep sedation, said Early, citing results from a separate survey sent to practicing clinicians.
Ongoing Shortages of CRNAs and Anesthesiologists
Shortages of anesthesiologists and CRNAs will continue to limit endoscopy procedure volume, especially in rural areas of the US, said Early.
The nation is expected to be short by 450,000 CRNAs this year and by 6300 anesthesiologists within a decade, she reported. Anesthesia providers are burned out or nearing retirement age, and there are not enough residency programs to produce new anesthesiologists at the rate needed to meet the demand, she said.
Gastroenterologists have become reliant on anesthesia providers, but adding a clinician is more expensive and “doesn’t appear to resolve and improve safety as compared with endoscopist-directed sedation for routine procedures,” said Early.
When practicing clinicians were asked if they’d be interested in providing physician-directed propofol sedation, 20% said yes, while 35% said no. But 16% said they would want to provide moderate sedation after completing in-person training, and 19% said they would after completing online training.
It may take time for gastroenterologists to get appropriate training and reduce reliance on anesthesia providers, Early said. But she said it may be increasingly possible in states allowing endoscopist-directed, nurse-administered propofol, and with medications such as remimazolam, a rapid-acting benzodiazepine that has shown similar efficacy and lower adverse event rates than propofol.
There will have to be a really deliberate step in order to take back control of endoscopic sedation from anesthesia and start performing more modest sedation, she said.
Early reported having no conflicts.
A version of this article first appeared on Medscape.com.
FROM ACG 2025
FDA OKs Linzess for IBS With Constipation in Kids
, making it the first approved treatment for pediatric IBS-C.
The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.
Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.
IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval.
The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.
The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.
The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.
The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
, making it the first approved treatment for pediatric IBS-C.
The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.
Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.
IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval.
The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.
The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.
The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.
The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
, making it the first approved treatment for pediatric IBS-C.
The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.
Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.
IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval.
The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.
The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.
The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.
The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
Chance to Diagnose Eosinophilic Esophagitis in the ED Commonly Missed
PHOENIX — The opportunity to diagnose eosinophilic esophagitis (EoE) when patients present to the emergency department (ED) with the classic symptom of esophageal food impaction (EFI) is commonly missed, with necessary biopsies provided at strikingly low rates, despite guideline recommendations, new research showed.
“This is the first study to assess the rate of biopsies at time of esophageal food impaction in a large, real-world dataset of community practices,” the authors explained in research presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The findings underscore that “.”
Research shows patients with EoE, a chronic and progressive type 2 inflammatory disease, have an average delay of 4 years before being diagnosed, with a delay of up to 10 years in about a third of cases. With those delays comes the likelihood of disease progression.
The latest guidelines from the ACG indicate that for diagnosis, “from a practical standpoint,” the preferred approach is to obtain at least two to four biopsies from at least two distinct esophageal areas, while targeting areas of visual inflammation.
However, prior evidence suggests that the biopsies are commonly not performed when patients present with the symptoms of EFI.
To further investigate the management of EFI during and after ED visits in a real-world setting, first author Walker D. Redd, MD, Center for Gastrointestinal Biology and Disease, UNC School of Medicine, Chapel Hill, North Carolina, and colleagues conducted a retrospective cohort study of 2566 patients in a multistate gastrointestinal practice group at 143 care centers in seven US states.
The patients were treated for esophageal food or foreign body removal between 2018 and 2024.
Among them, 1434 patients received evaluation with esophagogastroduodenoscopy (EGD), with 754 having no EGD and 378 receiving EGD for non-EFI.
The patients had a mean age of 63, with nearly 60% being older than 60 years, and 44.9% were women.
At the index EGD, only 19% had records of having esophageal biopsies. Among them, nearly half, 47%, were determined to have biopsy-confirmed EoE.
Of those who did not receive biopsies, only 7% had records of having received a follow-up EGD with an esophageal biopsy within 1 year, with 40% of those having EoE confirmed from a biopsy.
Among the remaining 93% of patients who had no record of such follow-up care within 1 year, 41% were lost to follow-up.
“We found that only about one fifth of patients had esophageal biopsies collected at the time of esophageal food impaction, which is similar to previous reports,” Redd said.
Overall, “esophageal biopsy rates at the time of esophageal food impaction remain low, and follow-up EGD with biopsy rates are also very low.”
Responding to a comment from the audience, Redd agreed that a limitation of the study was the scenario of patients from out of town being treated at an ED and then going back home, where their follow-up status may not be known.
Nevertheless, awareness of the low rates “represent an important opportunity to reduce the diagnostic delay and improve quality of care in EoE,” he said.
Commenting on the study, Danny Issa, MD, an interventional gastroenterologist at UCLA Health, agreed that the low rates of follow-up were troubling.
“Only 1 in 10 is a very low rate of follow-up endoscopy,” he told GI & Hepatology News.
“These results show we need to encourage quality improvement initiatives to make sure those patients are followed up,” he said.
Furthermore, “additional studies are needed to better understand the barriers behind the lack of follow-up, which were not addressed fully in the study.”
Co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist at Valley Medical Group, in Paramus, New Jersey, added that “the point that needs to be made is that these patients need biopsies so you can diagnose and subsequently treat them.”
Redd reported having a consulting relationship with Sanofi. Issa reported having relationships with Boston Scientific and Eli Lilly. Chokhavatia had no disclosures to report.
A version of this article first appeared on Medscape.com.
PHOENIX — The opportunity to diagnose eosinophilic esophagitis (EoE) when patients present to the emergency department (ED) with the classic symptom of esophageal food impaction (EFI) is commonly missed, with necessary biopsies provided at strikingly low rates, despite guideline recommendations, new research showed.
“This is the first study to assess the rate of biopsies at time of esophageal food impaction in a large, real-world dataset of community practices,” the authors explained in research presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The findings underscore that “.”
Research shows patients with EoE, a chronic and progressive type 2 inflammatory disease, have an average delay of 4 years before being diagnosed, with a delay of up to 10 years in about a third of cases. With those delays comes the likelihood of disease progression.
The latest guidelines from the ACG indicate that for diagnosis, “from a practical standpoint,” the preferred approach is to obtain at least two to four biopsies from at least two distinct esophageal areas, while targeting areas of visual inflammation.
However, prior evidence suggests that the biopsies are commonly not performed when patients present with the symptoms of EFI.
To further investigate the management of EFI during and after ED visits in a real-world setting, first author Walker D. Redd, MD, Center for Gastrointestinal Biology and Disease, UNC School of Medicine, Chapel Hill, North Carolina, and colleagues conducted a retrospective cohort study of 2566 patients in a multistate gastrointestinal practice group at 143 care centers in seven US states.
The patients were treated for esophageal food or foreign body removal between 2018 and 2024.
Among them, 1434 patients received evaluation with esophagogastroduodenoscopy (EGD), with 754 having no EGD and 378 receiving EGD for non-EFI.
The patients had a mean age of 63, with nearly 60% being older than 60 years, and 44.9% were women.
At the index EGD, only 19% had records of having esophageal biopsies. Among them, nearly half, 47%, were determined to have biopsy-confirmed EoE.
Of those who did not receive biopsies, only 7% had records of having received a follow-up EGD with an esophageal biopsy within 1 year, with 40% of those having EoE confirmed from a biopsy.
Among the remaining 93% of patients who had no record of such follow-up care within 1 year, 41% were lost to follow-up.
“We found that only about one fifth of patients had esophageal biopsies collected at the time of esophageal food impaction, which is similar to previous reports,” Redd said.
Overall, “esophageal biopsy rates at the time of esophageal food impaction remain low, and follow-up EGD with biopsy rates are also very low.”
Responding to a comment from the audience, Redd agreed that a limitation of the study was the scenario of patients from out of town being treated at an ED and then going back home, where their follow-up status may not be known.
Nevertheless, awareness of the low rates “represent an important opportunity to reduce the diagnostic delay and improve quality of care in EoE,” he said.
Commenting on the study, Danny Issa, MD, an interventional gastroenterologist at UCLA Health, agreed that the low rates of follow-up were troubling.
“Only 1 in 10 is a very low rate of follow-up endoscopy,” he told GI & Hepatology News.
“These results show we need to encourage quality improvement initiatives to make sure those patients are followed up,” he said.
Furthermore, “additional studies are needed to better understand the barriers behind the lack of follow-up, which were not addressed fully in the study.”
Co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist at Valley Medical Group, in Paramus, New Jersey, added that “the point that needs to be made is that these patients need biopsies so you can diagnose and subsequently treat them.”
Redd reported having a consulting relationship with Sanofi. Issa reported having relationships with Boston Scientific and Eli Lilly. Chokhavatia had no disclosures to report.
A version of this article first appeared on Medscape.com.
PHOENIX — The opportunity to diagnose eosinophilic esophagitis (EoE) when patients present to the emergency department (ED) with the classic symptom of esophageal food impaction (EFI) is commonly missed, with necessary biopsies provided at strikingly low rates, despite guideline recommendations, new research showed.
“This is the first study to assess the rate of biopsies at time of esophageal food impaction in a large, real-world dataset of community practices,” the authors explained in research presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The findings underscore that “.”
Research shows patients with EoE, a chronic and progressive type 2 inflammatory disease, have an average delay of 4 years before being diagnosed, with a delay of up to 10 years in about a third of cases. With those delays comes the likelihood of disease progression.
The latest guidelines from the ACG indicate that for diagnosis, “from a practical standpoint,” the preferred approach is to obtain at least two to four biopsies from at least two distinct esophageal areas, while targeting areas of visual inflammation.
However, prior evidence suggests that the biopsies are commonly not performed when patients present with the symptoms of EFI.
To further investigate the management of EFI during and after ED visits in a real-world setting, first author Walker D. Redd, MD, Center for Gastrointestinal Biology and Disease, UNC School of Medicine, Chapel Hill, North Carolina, and colleagues conducted a retrospective cohort study of 2566 patients in a multistate gastrointestinal practice group at 143 care centers in seven US states.
The patients were treated for esophageal food or foreign body removal between 2018 and 2024.
Among them, 1434 patients received evaluation with esophagogastroduodenoscopy (EGD), with 754 having no EGD and 378 receiving EGD for non-EFI.
The patients had a mean age of 63, with nearly 60% being older than 60 years, and 44.9% were women.
At the index EGD, only 19% had records of having esophageal biopsies. Among them, nearly half, 47%, were determined to have biopsy-confirmed EoE.
Of those who did not receive biopsies, only 7% had records of having received a follow-up EGD with an esophageal biopsy within 1 year, with 40% of those having EoE confirmed from a biopsy.
Among the remaining 93% of patients who had no record of such follow-up care within 1 year, 41% were lost to follow-up.
“We found that only about one fifth of patients had esophageal biopsies collected at the time of esophageal food impaction, which is similar to previous reports,” Redd said.
Overall, “esophageal biopsy rates at the time of esophageal food impaction remain low, and follow-up EGD with biopsy rates are also very low.”
Responding to a comment from the audience, Redd agreed that a limitation of the study was the scenario of patients from out of town being treated at an ED and then going back home, where their follow-up status may not be known.
Nevertheless, awareness of the low rates “represent an important opportunity to reduce the diagnostic delay and improve quality of care in EoE,” he said.
Commenting on the study, Danny Issa, MD, an interventional gastroenterologist at UCLA Health, agreed that the low rates of follow-up were troubling.
“Only 1 in 10 is a very low rate of follow-up endoscopy,” he told GI & Hepatology News.
“These results show we need to encourage quality improvement initiatives to make sure those patients are followed up,” he said.
Furthermore, “additional studies are needed to better understand the barriers behind the lack of follow-up, which were not addressed fully in the study.”
Co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist at Valley Medical Group, in Paramus, New Jersey, added that “the point that needs to be made is that these patients need biopsies so you can diagnose and subsequently treat them.”
Redd reported having a consulting relationship with Sanofi. Issa reported having relationships with Boston Scientific and Eli Lilly. Chokhavatia had no disclosures to report.
A version of this article first appeared on Medscape.com.
FROM ACG 2025
Cholecystectomy Delay Linked to Substantially Increased Complication Risk
, regardless of the receipt of sphincterotomy or stenting, new research showed.
“These findings suggest an opportunity for systemic interventions, including prioritization algorithms and better perioperative coordination, to address preventable delays,” reported the authors in the study, presented at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
Choledocholithiasis can occur in up to 20% of symptomatic gallstone cases, and while guidelines recommend having a cholecystectomy concurrently with ERCP, data on the best timing is inconsistent and delays in gall bladder removal are consequently common.
One large study, for instance, the PONCHO trial conducted at 23 hospitals in Netherlands, showed complications to be significantly lower with same-admission vs interval cholecystectomy (4.7% vs 16.9%; P = .02).
Meanwhile, other research has suggested that delayed cholecystectomy is a preferred approach, allowing for removal when there is less inflammation.
Real world data meanwhile shows, despite the guidelines, the procedures are performed at the same time as ERCP only in about 41% of cases, first author Jessica El Halabi, MD, of the Johns Hopkins Hospital, Baltimore, said.
To further investigate outcomes associated with those delays, El Halabi and colleagues conducted a retrospective cohort study involving 507 patients admitted with choledocholithiasis at the hospital and community hospitals between 2005 and 2023 who had 12 months or more follow-up.
The patients had a mean age of 59 years and 59.4% were women.
Of the patients, 265 (52.3%) underwent early cholecystectomy, defined as surgery during the index admission, while 242 (47.7%) underwent delayed cholecystectomy, defined as postdischarge cholecystectomy or if cholecystectomy was not performed.
Overall, biliary complications occurred in as many as 23% of those who had delayed cholecystectomy compared with just 0.8% among those having the early cholecystectomy (P < .001).
Of patients who had delayed cholecystectomy and developed complications, 15.5% did so within 3 months, 6.5% by 6 months, and 1% by 12 months.
Among those who had ERCP with sphincterotomy, there were no significant differences in rates of biliary complications vs those who did not have sphincterotomy (26% vs 21%; P = .74), while stenting also did not reduce the risk (25% vs 27%; P = .81).
The leading reasons for delayed cholecystectomy included patients having a high surgical risk (27.3%), concurrent biliary pathology (19.2%), and physician preference (14%).
The findings underscore that “concurrent cholecystectomy is associated with the lowest risk of biliary complications,” El Halabi said.
“Delayed cholecystectomy is associated with an approximately 23% incidence of biliary complications with 1 year of initial admission, with the highest incidence occurring within 3 months,” she added. “Neither sphincterotomy nor stenting during ERCP mitigates this risk.”
“Early cholecystectomy during the index admission remains the most reliable strategy to reduce recurrent events.”
Findings Underscore Importance of Timing
Commenting on the study, Luis F. Lara, MD, division chief of digestive diseases at the University of Cincinnati, who co-moderated the session, agreed that evidence soundly supports early cholecystectomy.
“We also did a large study looking at this and there’s no doubt that doing it during the index admission has a tremendous effect on long-term outcomes,” Lara told GI & Hepatology News.
Lara noted that “part of it is people don’t show up again until they get sick again, so we don’t want to lose that opportunity the first time, during the index admission,” he said.
Lara’s previous studies have specifically documented how early cholecystectomy for acute biliary pancreatitis improves outcomes of hospitalization for cirrhosis and factors associated with early unplanned readmissions following same-admission cholecystectomy for acute biliary pancreatitis.
Akwi W. Asombang, MD, an interventional gastroenterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, both in Boston, agreed that the findings are important.
“We know that if a cholecystectomy is not performed in the same admission as ERCP, the stones in the gallbladder remain and may migrate out into the bile duct, resulting in further complications as described in the study,” Asombang, also a session co-moderator, told GI & Hepatology News.
She noted that the practice can vary between institutions based on factors including the availability of physicians to perform the cholecystectomy.
Potential complications in delaying the procedure can range from inflammation and pancreatitis to obstruction of the bile duct, “which then can result in cholangitis and eventually sepsis or even death,” Asombang cautioned.
“So the timing of the procedure with ERCP is definitely significant,” she said.
El Halabi and Asombang had no disclosures to report. Lara reported a relationship with AbbVie.
A version of this article first appeared on Medscape.com.
, regardless of the receipt of sphincterotomy or stenting, new research showed.
“These findings suggest an opportunity for systemic interventions, including prioritization algorithms and better perioperative coordination, to address preventable delays,” reported the authors in the study, presented at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
Choledocholithiasis can occur in up to 20% of symptomatic gallstone cases, and while guidelines recommend having a cholecystectomy concurrently with ERCP, data on the best timing is inconsistent and delays in gall bladder removal are consequently common.
One large study, for instance, the PONCHO trial conducted at 23 hospitals in Netherlands, showed complications to be significantly lower with same-admission vs interval cholecystectomy (4.7% vs 16.9%; P = .02).
Meanwhile, other research has suggested that delayed cholecystectomy is a preferred approach, allowing for removal when there is less inflammation.
Real world data meanwhile shows, despite the guidelines, the procedures are performed at the same time as ERCP only in about 41% of cases, first author Jessica El Halabi, MD, of the Johns Hopkins Hospital, Baltimore, said.
To further investigate outcomes associated with those delays, El Halabi and colleagues conducted a retrospective cohort study involving 507 patients admitted with choledocholithiasis at the hospital and community hospitals between 2005 and 2023 who had 12 months or more follow-up.
The patients had a mean age of 59 years and 59.4% were women.
Of the patients, 265 (52.3%) underwent early cholecystectomy, defined as surgery during the index admission, while 242 (47.7%) underwent delayed cholecystectomy, defined as postdischarge cholecystectomy or if cholecystectomy was not performed.
Overall, biliary complications occurred in as many as 23% of those who had delayed cholecystectomy compared with just 0.8% among those having the early cholecystectomy (P < .001).
Of patients who had delayed cholecystectomy and developed complications, 15.5% did so within 3 months, 6.5% by 6 months, and 1% by 12 months.
Among those who had ERCP with sphincterotomy, there were no significant differences in rates of biliary complications vs those who did not have sphincterotomy (26% vs 21%; P = .74), while stenting also did not reduce the risk (25% vs 27%; P = .81).
The leading reasons for delayed cholecystectomy included patients having a high surgical risk (27.3%), concurrent biliary pathology (19.2%), and physician preference (14%).
The findings underscore that “concurrent cholecystectomy is associated with the lowest risk of biliary complications,” El Halabi said.
“Delayed cholecystectomy is associated with an approximately 23% incidence of biliary complications with 1 year of initial admission, with the highest incidence occurring within 3 months,” she added. “Neither sphincterotomy nor stenting during ERCP mitigates this risk.”
“Early cholecystectomy during the index admission remains the most reliable strategy to reduce recurrent events.”
Findings Underscore Importance of Timing
Commenting on the study, Luis F. Lara, MD, division chief of digestive diseases at the University of Cincinnati, who co-moderated the session, agreed that evidence soundly supports early cholecystectomy.
“We also did a large study looking at this and there’s no doubt that doing it during the index admission has a tremendous effect on long-term outcomes,” Lara told GI & Hepatology News.
Lara noted that “part of it is people don’t show up again until they get sick again, so we don’t want to lose that opportunity the first time, during the index admission,” he said.
Lara’s previous studies have specifically documented how early cholecystectomy for acute biliary pancreatitis improves outcomes of hospitalization for cirrhosis and factors associated with early unplanned readmissions following same-admission cholecystectomy for acute biliary pancreatitis.
Akwi W. Asombang, MD, an interventional gastroenterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, both in Boston, agreed that the findings are important.
“We know that if a cholecystectomy is not performed in the same admission as ERCP, the stones in the gallbladder remain and may migrate out into the bile duct, resulting in further complications as described in the study,” Asombang, also a session co-moderator, told GI & Hepatology News.
She noted that the practice can vary between institutions based on factors including the availability of physicians to perform the cholecystectomy.
Potential complications in delaying the procedure can range from inflammation and pancreatitis to obstruction of the bile duct, “which then can result in cholangitis and eventually sepsis or even death,” Asombang cautioned.
“So the timing of the procedure with ERCP is definitely significant,” she said.
El Halabi and Asombang had no disclosures to report. Lara reported a relationship with AbbVie.
A version of this article first appeared on Medscape.com.
, regardless of the receipt of sphincterotomy or stenting, new research showed.
“These findings suggest an opportunity for systemic interventions, including prioritization algorithms and better perioperative coordination, to address preventable delays,” reported the authors in the study, presented at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
Choledocholithiasis can occur in up to 20% of symptomatic gallstone cases, and while guidelines recommend having a cholecystectomy concurrently with ERCP, data on the best timing is inconsistent and delays in gall bladder removal are consequently common.
One large study, for instance, the PONCHO trial conducted at 23 hospitals in Netherlands, showed complications to be significantly lower with same-admission vs interval cholecystectomy (4.7% vs 16.9%; P = .02).
Meanwhile, other research has suggested that delayed cholecystectomy is a preferred approach, allowing for removal when there is less inflammation.
Real world data meanwhile shows, despite the guidelines, the procedures are performed at the same time as ERCP only in about 41% of cases, first author Jessica El Halabi, MD, of the Johns Hopkins Hospital, Baltimore, said.
To further investigate outcomes associated with those delays, El Halabi and colleagues conducted a retrospective cohort study involving 507 patients admitted with choledocholithiasis at the hospital and community hospitals between 2005 and 2023 who had 12 months or more follow-up.
The patients had a mean age of 59 years and 59.4% were women.
Of the patients, 265 (52.3%) underwent early cholecystectomy, defined as surgery during the index admission, while 242 (47.7%) underwent delayed cholecystectomy, defined as postdischarge cholecystectomy or if cholecystectomy was not performed.
Overall, biliary complications occurred in as many as 23% of those who had delayed cholecystectomy compared with just 0.8% among those having the early cholecystectomy (P < .001).
Of patients who had delayed cholecystectomy and developed complications, 15.5% did so within 3 months, 6.5% by 6 months, and 1% by 12 months.
Among those who had ERCP with sphincterotomy, there were no significant differences in rates of biliary complications vs those who did not have sphincterotomy (26% vs 21%; P = .74), while stenting also did not reduce the risk (25% vs 27%; P = .81).
The leading reasons for delayed cholecystectomy included patients having a high surgical risk (27.3%), concurrent biliary pathology (19.2%), and physician preference (14%).
The findings underscore that “concurrent cholecystectomy is associated with the lowest risk of biliary complications,” El Halabi said.
“Delayed cholecystectomy is associated with an approximately 23% incidence of biliary complications with 1 year of initial admission, with the highest incidence occurring within 3 months,” she added. “Neither sphincterotomy nor stenting during ERCP mitigates this risk.”
“Early cholecystectomy during the index admission remains the most reliable strategy to reduce recurrent events.”
Findings Underscore Importance of Timing
Commenting on the study, Luis F. Lara, MD, division chief of digestive diseases at the University of Cincinnati, who co-moderated the session, agreed that evidence soundly supports early cholecystectomy.
“We also did a large study looking at this and there’s no doubt that doing it during the index admission has a tremendous effect on long-term outcomes,” Lara told GI & Hepatology News.
Lara noted that “part of it is people don’t show up again until they get sick again, so we don’t want to lose that opportunity the first time, during the index admission,” he said.
Lara’s previous studies have specifically documented how early cholecystectomy for acute biliary pancreatitis improves outcomes of hospitalization for cirrhosis and factors associated with early unplanned readmissions following same-admission cholecystectomy for acute biliary pancreatitis.
Akwi W. Asombang, MD, an interventional gastroenterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, both in Boston, agreed that the findings are important.
“We know that if a cholecystectomy is not performed in the same admission as ERCP, the stones in the gallbladder remain and may migrate out into the bile duct, resulting in further complications as described in the study,” Asombang, also a session co-moderator, told GI & Hepatology News.
She noted that the practice can vary between institutions based on factors including the availability of physicians to perform the cholecystectomy.
Potential complications in delaying the procedure can range from inflammation and pancreatitis to obstruction of the bile duct, “which then can result in cholangitis and eventually sepsis or even death,” Asombang cautioned.
“So the timing of the procedure with ERCP is definitely significant,” she said.
El Halabi and Asombang had no disclosures to report. Lara reported a relationship with AbbVie.
A version of this article first appeared on Medscape.com.
FROM ACG 2025
Resmetirom Reduces Liver Stiffness in MASH Cirrhosis
PHOENIX — according to the results of a new study.
As well as showing sustained reduction in liver stiffness on vibration-controlled transient elastography (VCTE) after 2 years of treatment with resmetirom, the study suggested that up to 35% of patients could “potentially reverse their cirrhosis,” said lead author Naim Alkhouri, MD, chief medical officer and director of the steatotic liver program at Arizona Liver Health in Phoenix.
Alkhouri presented data on patients with compensated cirrhosis from a 1-year open-label extension of the already-completed MAESTRO-NAFLD-1 study at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The FDA approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals) in 2024 for MASH and moderate-to-advanced liver fibrosis (consistent with stage F2 and F3 disease), to be used in conjunction with diet and exercise. The agency granted the once-daily, oral thyroid hormone receptor beta-selective agonist breakthrough therapy designation and priority review.
According to the American Liver Foundation, about 5% of adults in the US have MASH — one of the leading causes of liver transplantation in the country. There is currently no FDA-approved therapy for compensated cirrhosis caused by MASH, said Alkhouri. Patients with MASH cirrhosis with clinically significant portal hypertension (CSPH) experience major adverse liver outcomes.
In an analysis of 122 patients with Child Pugh A MASH cirrhosis who completed both a year in an open-label arm of MAESTRO-NAFLD-1 and a 1-year extension, 113 (93%) completed 2 years of treatment with resmetirom (80 mg). Of the 122 patients, only 114 received MRI proton density fat fraction (MRI-PDFF) testing — 93 (82%) had a baseline of > 5% indicating cirrhosis, while 21 (18%) had an MRI-PDFF of < 5%.
Patients were assessed for baseline portal hypertension (Baveno VII) with FibroScan VCTE and platelet count, which was confirmed using magnetic resonance elastography (MRE). Noninvasive biomarkers and imaging were analyzed at baseline and out to 2 years.
At baseline, 63% of patients were categorized as probable/definitive CSPH (Baveno VII). At 1 year of treatment with resmetirom, 20% of patients who were CSPH positive no longer met the criteria, and at 2 years this number had increased to 28%.
After 2 years of treatment, more than half of the patients had a sustained reduction in liver stiffness of more than 25%, as measured by VCTE; and 35% of patients with confirmed F4 at baseline (liver biopsy F4 and/or platelets < 140/MRE ≥ 5 with VCTE ≥ 15) had a conversion to F3.
Patients taking resmetirom also had significant improvements in MRI-PDFF and MRE at 2 years. Almost a third of those with a baseline MRI-PDFF > 5% improved, while 43% of those with a baseline of < 5% improved.
Although 113 patients had an adverse event — primarily gastrointestinal — the observed events were consistent with previous studies. Twenty-seven patients had a serious adverse event, but none were related to the study drug, said Alkhouri. The researchers reported that only 8% of patients discontinued the medication.
Changing the Treatment Landscape for MASH-Related Cirrhosis
When asked to comment by GI & Hepatology News, Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, said that “reversal of cirrhosis from F4 to F3 and reduction of portal hypertension are quite surprising, since cirrhosis typically progresses slowly.”
Ayesh said it was notable that the researchers had used imaging to confirm both functional and hemodynamic improvements in liver architecture not just biochemical changes. Given the results, “clinicians may reasonably consider off-label use in selected compensated patients until more outcome data become available,” he said.
A phase 3 study is underway to examine those outcomes, MAESTRO-NASH OUTCOMES, with 845 patients with MASH cirrhosis, and should be completed in 2027.
“Resmetirom could change the treatment landscape for MASH-related cirrhosis,” said Ayesh, adding, “this drug offers a chance to target the disease process itself,” while other therapies focus on preventing complications.
“For patients without access to liver transplant, a therapy that can slow or reverse disease progression could be transformative,” he told GI & Hepatology News.
Alkhouri disclosed that he is a consultant and speaker for Madrigal Pharmaceuticals. Three coauthors are Madrigal employees and own stock options in the company. Two coauthors are Madrigal consultants and advisers. Ayesh reported no conflicts.
A version of this article appeared on Medscape.com.
PHOENIX — according to the results of a new study.
As well as showing sustained reduction in liver stiffness on vibration-controlled transient elastography (VCTE) after 2 years of treatment with resmetirom, the study suggested that up to 35% of patients could “potentially reverse their cirrhosis,” said lead author Naim Alkhouri, MD, chief medical officer and director of the steatotic liver program at Arizona Liver Health in Phoenix.
Alkhouri presented data on patients with compensated cirrhosis from a 1-year open-label extension of the already-completed MAESTRO-NAFLD-1 study at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The FDA approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals) in 2024 for MASH and moderate-to-advanced liver fibrosis (consistent with stage F2 and F3 disease), to be used in conjunction with diet and exercise. The agency granted the once-daily, oral thyroid hormone receptor beta-selective agonist breakthrough therapy designation and priority review.
According to the American Liver Foundation, about 5% of adults in the US have MASH — one of the leading causes of liver transplantation in the country. There is currently no FDA-approved therapy for compensated cirrhosis caused by MASH, said Alkhouri. Patients with MASH cirrhosis with clinically significant portal hypertension (CSPH) experience major adverse liver outcomes.
In an analysis of 122 patients with Child Pugh A MASH cirrhosis who completed both a year in an open-label arm of MAESTRO-NAFLD-1 and a 1-year extension, 113 (93%) completed 2 years of treatment with resmetirom (80 mg). Of the 122 patients, only 114 received MRI proton density fat fraction (MRI-PDFF) testing — 93 (82%) had a baseline of > 5% indicating cirrhosis, while 21 (18%) had an MRI-PDFF of < 5%.
Patients were assessed for baseline portal hypertension (Baveno VII) with FibroScan VCTE and platelet count, which was confirmed using magnetic resonance elastography (MRE). Noninvasive biomarkers and imaging were analyzed at baseline and out to 2 years.
At baseline, 63% of patients were categorized as probable/definitive CSPH (Baveno VII). At 1 year of treatment with resmetirom, 20% of patients who were CSPH positive no longer met the criteria, and at 2 years this number had increased to 28%.
After 2 years of treatment, more than half of the patients had a sustained reduction in liver stiffness of more than 25%, as measured by VCTE; and 35% of patients with confirmed F4 at baseline (liver biopsy F4 and/or platelets < 140/MRE ≥ 5 with VCTE ≥ 15) had a conversion to F3.
Patients taking resmetirom also had significant improvements in MRI-PDFF and MRE at 2 years. Almost a third of those with a baseline MRI-PDFF > 5% improved, while 43% of those with a baseline of < 5% improved.
Although 113 patients had an adverse event — primarily gastrointestinal — the observed events were consistent with previous studies. Twenty-seven patients had a serious adverse event, but none were related to the study drug, said Alkhouri. The researchers reported that only 8% of patients discontinued the medication.
Changing the Treatment Landscape for MASH-Related Cirrhosis
When asked to comment by GI & Hepatology News, Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, said that “reversal of cirrhosis from F4 to F3 and reduction of portal hypertension are quite surprising, since cirrhosis typically progresses slowly.”
Ayesh said it was notable that the researchers had used imaging to confirm both functional and hemodynamic improvements in liver architecture not just biochemical changes. Given the results, “clinicians may reasonably consider off-label use in selected compensated patients until more outcome data become available,” he said.
A phase 3 study is underway to examine those outcomes, MAESTRO-NASH OUTCOMES, with 845 patients with MASH cirrhosis, and should be completed in 2027.
“Resmetirom could change the treatment landscape for MASH-related cirrhosis,” said Ayesh, adding, “this drug offers a chance to target the disease process itself,” while other therapies focus on preventing complications.
“For patients without access to liver transplant, a therapy that can slow or reverse disease progression could be transformative,” he told GI & Hepatology News.
Alkhouri disclosed that he is a consultant and speaker for Madrigal Pharmaceuticals. Three coauthors are Madrigal employees and own stock options in the company. Two coauthors are Madrigal consultants and advisers. Ayesh reported no conflicts.
A version of this article appeared on Medscape.com.
PHOENIX — according to the results of a new study.
As well as showing sustained reduction in liver stiffness on vibration-controlled transient elastography (VCTE) after 2 years of treatment with resmetirom, the study suggested that up to 35% of patients could “potentially reverse their cirrhosis,” said lead author Naim Alkhouri, MD, chief medical officer and director of the steatotic liver program at Arizona Liver Health in Phoenix.
Alkhouri presented data on patients with compensated cirrhosis from a 1-year open-label extension of the already-completed MAESTRO-NAFLD-1 study at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
The FDA approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals) in 2024 for MASH and moderate-to-advanced liver fibrosis (consistent with stage F2 and F3 disease), to be used in conjunction with diet and exercise. The agency granted the once-daily, oral thyroid hormone receptor beta-selective agonist breakthrough therapy designation and priority review.
According to the American Liver Foundation, about 5% of adults in the US have MASH — one of the leading causes of liver transplantation in the country. There is currently no FDA-approved therapy for compensated cirrhosis caused by MASH, said Alkhouri. Patients with MASH cirrhosis with clinically significant portal hypertension (CSPH) experience major adverse liver outcomes.
In an analysis of 122 patients with Child Pugh A MASH cirrhosis who completed both a year in an open-label arm of MAESTRO-NAFLD-1 and a 1-year extension, 113 (93%) completed 2 years of treatment with resmetirom (80 mg). Of the 122 patients, only 114 received MRI proton density fat fraction (MRI-PDFF) testing — 93 (82%) had a baseline of > 5% indicating cirrhosis, while 21 (18%) had an MRI-PDFF of < 5%.
Patients were assessed for baseline portal hypertension (Baveno VII) with FibroScan VCTE and platelet count, which was confirmed using magnetic resonance elastography (MRE). Noninvasive biomarkers and imaging were analyzed at baseline and out to 2 years.
At baseline, 63% of patients were categorized as probable/definitive CSPH (Baveno VII). At 1 year of treatment with resmetirom, 20% of patients who were CSPH positive no longer met the criteria, and at 2 years this number had increased to 28%.
After 2 years of treatment, more than half of the patients had a sustained reduction in liver stiffness of more than 25%, as measured by VCTE; and 35% of patients with confirmed F4 at baseline (liver biopsy F4 and/or platelets < 140/MRE ≥ 5 with VCTE ≥ 15) had a conversion to F3.
Patients taking resmetirom also had significant improvements in MRI-PDFF and MRE at 2 years. Almost a third of those with a baseline MRI-PDFF > 5% improved, while 43% of those with a baseline of < 5% improved.
Although 113 patients had an adverse event — primarily gastrointestinal — the observed events were consistent with previous studies. Twenty-seven patients had a serious adverse event, but none were related to the study drug, said Alkhouri. The researchers reported that only 8% of patients discontinued the medication.
Changing the Treatment Landscape for MASH-Related Cirrhosis
When asked to comment by GI & Hepatology News, Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, said that “reversal of cirrhosis from F4 to F3 and reduction of portal hypertension are quite surprising, since cirrhosis typically progresses slowly.”
Ayesh said it was notable that the researchers had used imaging to confirm both functional and hemodynamic improvements in liver architecture not just biochemical changes. Given the results, “clinicians may reasonably consider off-label use in selected compensated patients until more outcome data become available,” he said.
A phase 3 study is underway to examine those outcomes, MAESTRO-NASH OUTCOMES, with 845 patients with MASH cirrhosis, and should be completed in 2027.
“Resmetirom could change the treatment landscape for MASH-related cirrhosis,” said Ayesh, adding, “this drug offers a chance to target the disease process itself,” while other therapies focus on preventing complications.
“For patients without access to liver transplant, a therapy that can slow or reverse disease progression could be transformative,” he told GI & Hepatology News.
Alkhouri disclosed that he is a consultant and speaker for Madrigal Pharmaceuticals. Three coauthors are Madrigal employees and own stock options in the company. Two coauthors are Madrigal consultants and advisers. Ayesh reported no conflicts.
A version of this article appeared on Medscape.com.
FROM ACG 2025
Patients With a Positive FIT Fail to Get Follow-Up Colonoscopies
PHOENIX — Patients with or without polyp removal in an index colonoscopy commonly receive follow-up surveillance with a fecal immunochemical test (FIT), yet many of these patients do not receive a recommended colonoscopy after a positive FIT.
“In this large US study, we found interval FITs are frequently performed in patients with and without prior polypectomy,” said first author Natalie J. Wilson, MD, of the University of Minnesota in Minneapolis, while presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
“ and colorectal cancer, regardless of polypectomy history,” Wilson said.
Guideline recommendations stress the need for follow-up surveillance with a colonoscopy, particularly in patients who have had a prior polypectomy, because of the higher risk.
Reasons patients may instead turn to FIT may include cost or other factors, she said.
To determine just how often that happens, how having a previous polypectomy affects FIT results, and how adherent patients are to follow up if a FIT result is positive, Wilson and her colleagues evaluated data from nearly 4.8 million individuals in the Veterans Health Administration Corporate Data Warehouse who underwent colonoscopy between 2000 and 2024.
Of the patients, 10.9% were found to have subsequently received interval FIT within 10 years of the index colonoscopy, and of those patients, nearly half (49.9%) had received a polypectomy at the index colonoscopy.
The average time from the colonoscopy/polypectomy to the interval FIT was 5.9 years (5.6 years in the polypectomy group vs 6.2 years in the non-polypectomy group).
Among the FIT screenings, results were positive in 17.2% of post-polypectomy patients and 14.1% of patients with no prior polypectomy, indicating a history of polypectomy to be predictive of a positive interval FIT (odds ratio [OR], 1.12; P < .0001).
Notably, while a follow-up colonoscopy is considered essential following a positive FIT result — and having a previous polypectomy should add further urgency to the matter — the study showed only 50.4% of those who had an earlier polypectomy went on to receive the recommended follow-up colonoscopy after a positive follow-up FIT, and the rate was 49.3% among those who had not received a polypectomy (P = .001).
For those who did receive a follow-up colonoscopy after a positive FIT, the duration of time to receiving the colonoscopy was longer among those who had a prior polypectomy, at 2.9 months compared with 2.5 months in the non-polypectomy group (P < .001).
Colonoscopy results following a positive FIT showed higher rates of detections among patients who had prior polypectomies than among those with no prior polypectomy, including tubular adenomas (54.7% vs 45.8%), tubulovillous adenomas (5.6% vs 4.7%), adenomas with high-grade dysplasia (0.8% vs 0.7%), sessile serrated lesions (3.52% vs 2.4%), advanced colorectal neoplasia (9.2% vs 7.9%), and colorectal cancer (3.3% vs 3.0%).
However, a prior polypectomy was not independently predictive of colorectal cancer (OR, 0.96; P = .65) or advanced colorectal neoplasia (OR, 0.97; P = .57) in the post-colonoscopy interval FIT.
The findings underscore that “positive results carried a high risk of advanced neoplasia or cancer, irrespective of prior polypectomy history,” Wilson said.
Clinicians Must ‘Do a Better Job’
Commenting on the study, William D. Chey, MD, AGAF, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, noted that the study “addresses one of the biggest challenges we face as a profession, which is making sure that patients who have a positive stool test get a colonoscopy.”
He noted that the low rate of just 50% of recipients of positive FITs going on to receive a colonoscopy is consistent with what is observed in other trials.
“Other data suggests that the rate might even be significantly higher — at 70%-80%, depending upon the population and the test,” Chey told Medscape Medical News.
Reasons for the failure to receive the follow-up testing range from income restrictions (due to the high cost of a colonoscopy, especially if not covered by insurance), education, speaking a foreign language, and other factors, he said.
The relatively high rates of colon cancers detected by FIT in the study, in those with and without a prior polypectomy, along with findings from other studies “should raise questions about whether there might be a role for FIT testing in addition to colonoscopy.” However, much stronger evidence would be needed, Chey noted.
In the meantime, a key issue is “how do we do a better job of making sure that individuals who have a positive FIT test get a colonoscopy,” he said.
“I think a lot of this is going to come down to how it’s done at the primary care level.”
Chey added that in that, and any other setting, “the main message that needs to get out to people who are undergoing stool-based screening is that the stool test is only the first part of the screening process, and if it’s positive, a follow-up colonoscopy must be performed.”
“Otherwise, the stool-based test is of no value.”
Wilson had no disclosures to report. Chey’s disclosures included consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestlé, Phathom, Redhill, Salix/Valeant, Takeda, and Vibrant.
A version of this article appeared on Medscape.com .
PHOENIX — Patients with or without polyp removal in an index colonoscopy commonly receive follow-up surveillance with a fecal immunochemical test (FIT), yet many of these patients do not receive a recommended colonoscopy after a positive FIT.
“In this large US study, we found interval FITs are frequently performed in patients with and without prior polypectomy,” said first author Natalie J. Wilson, MD, of the University of Minnesota in Minneapolis, while presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
“ and colorectal cancer, regardless of polypectomy history,” Wilson said.
Guideline recommendations stress the need for follow-up surveillance with a colonoscopy, particularly in patients who have had a prior polypectomy, because of the higher risk.
Reasons patients may instead turn to FIT may include cost or other factors, she said.
To determine just how often that happens, how having a previous polypectomy affects FIT results, and how adherent patients are to follow up if a FIT result is positive, Wilson and her colleagues evaluated data from nearly 4.8 million individuals in the Veterans Health Administration Corporate Data Warehouse who underwent colonoscopy between 2000 and 2024.
Of the patients, 10.9% were found to have subsequently received interval FIT within 10 years of the index colonoscopy, and of those patients, nearly half (49.9%) had received a polypectomy at the index colonoscopy.
The average time from the colonoscopy/polypectomy to the interval FIT was 5.9 years (5.6 years in the polypectomy group vs 6.2 years in the non-polypectomy group).
Among the FIT screenings, results were positive in 17.2% of post-polypectomy patients and 14.1% of patients with no prior polypectomy, indicating a history of polypectomy to be predictive of a positive interval FIT (odds ratio [OR], 1.12; P < .0001).
Notably, while a follow-up colonoscopy is considered essential following a positive FIT result — and having a previous polypectomy should add further urgency to the matter — the study showed only 50.4% of those who had an earlier polypectomy went on to receive the recommended follow-up colonoscopy after a positive follow-up FIT, and the rate was 49.3% among those who had not received a polypectomy (P = .001).
For those who did receive a follow-up colonoscopy after a positive FIT, the duration of time to receiving the colonoscopy was longer among those who had a prior polypectomy, at 2.9 months compared with 2.5 months in the non-polypectomy group (P < .001).
Colonoscopy results following a positive FIT showed higher rates of detections among patients who had prior polypectomies than among those with no prior polypectomy, including tubular adenomas (54.7% vs 45.8%), tubulovillous adenomas (5.6% vs 4.7%), adenomas with high-grade dysplasia (0.8% vs 0.7%), sessile serrated lesions (3.52% vs 2.4%), advanced colorectal neoplasia (9.2% vs 7.9%), and colorectal cancer (3.3% vs 3.0%).
However, a prior polypectomy was not independently predictive of colorectal cancer (OR, 0.96; P = .65) or advanced colorectal neoplasia (OR, 0.97; P = .57) in the post-colonoscopy interval FIT.
The findings underscore that “positive results carried a high risk of advanced neoplasia or cancer, irrespective of prior polypectomy history,” Wilson said.
Clinicians Must ‘Do a Better Job’
Commenting on the study, William D. Chey, MD, AGAF, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, noted that the study “addresses one of the biggest challenges we face as a profession, which is making sure that patients who have a positive stool test get a colonoscopy.”
He noted that the low rate of just 50% of recipients of positive FITs going on to receive a colonoscopy is consistent with what is observed in other trials.
“Other data suggests that the rate might even be significantly higher — at 70%-80%, depending upon the population and the test,” Chey told Medscape Medical News.
Reasons for the failure to receive the follow-up testing range from income restrictions (due to the high cost of a colonoscopy, especially if not covered by insurance), education, speaking a foreign language, and other factors, he said.
The relatively high rates of colon cancers detected by FIT in the study, in those with and without a prior polypectomy, along with findings from other studies “should raise questions about whether there might be a role for FIT testing in addition to colonoscopy.” However, much stronger evidence would be needed, Chey noted.
In the meantime, a key issue is “how do we do a better job of making sure that individuals who have a positive FIT test get a colonoscopy,” he said.
“I think a lot of this is going to come down to how it’s done at the primary care level.”
Chey added that in that, and any other setting, “the main message that needs to get out to people who are undergoing stool-based screening is that the stool test is only the first part of the screening process, and if it’s positive, a follow-up colonoscopy must be performed.”
“Otherwise, the stool-based test is of no value.”
Wilson had no disclosures to report. Chey’s disclosures included consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestlé, Phathom, Redhill, Salix/Valeant, Takeda, and Vibrant.
A version of this article appeared on Medscape.com .
PHOENIX — Patients with or without polyp removal in an index colonoscopy commonly receive follow-up surveillance with a fecal immunochemical test (FIT), yet many of these patients do not receive a recommended colonoscopy after a positive FIT.
“In this large US study, we found interval FITs are frequently performed in patients with and without prior polypectomy,” said first author Natalie J. Wilson, MD, of the University of Minnesota in Minneapolis, while presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.
“ and colorectal cancer, regardless of polypectomy history,” Wilson said.
Guideline recommendations stress the need for follow-up surveillance with a colonoscopy, particularly in patients who have had a prior polypectomy, because of the higher risk.
Reasons patients may instead turn to FIT may include cost or other factors, she said.
To determine just how often that happens, how having a previous polypectomy affects FIT results, and how adherent patients are to follow up if a FIT result is positive, Wilson and her colleagues evaluated data from nearly 4.8 million individuals in the Veterans Health Administration Corporate Data Warehouse who underwent colonoscopy between 2000 and 2024.
Of the patients, 10.9% were found to have subsequently received interval FIT within 10 years of the index colonoscopy, and of those patients, nearly half (49.9%) had received a polypectomy at the index colonoscopy.
The average time from the colonoscopy/polypectomy to the interval FIT was 5.9 years (5.6 years in the polypectomy group vs 6.2 years in the non-polypectomy group).
Among the FIT screenings, results were positive in 17.2% of post-polypectomy patients and 14.1% of patients with no prior polypectomy, indicating a history of polypectomy to be predictive of a positive interval FIT (odds ratio [OR], 1.12; P < .0001).
Notably, while a follow-up colonoscopy is considered essential following a positive FIT result — and having a previous polypectomy should add further urgency to the matter — the study showed only 50.4% of those who had an earlier polypectomy went on to receive the recommended follow-up colonoscopy after a positive follow-up FIT, and the rate was 49.3% among those who had not received a polypectomy (P = .001).
For those who did receive a follow-up colonoscopy after a positive FIT, the duration of time to receiving the colonoscopy was longer among those who had a prior polypectomy, at 2.9 months compared with 2.5 months in the non-polypectomy group (P < .001).
Colonoscopy results following a positive FIT showed higher rates of detections among patients who had prior polypectomies than among those with no prior polypectomy, including tubular adenomas (54.7% vs 45.8%), tubulovillous adenomas (5.6% vs 4.7%), adenomas with high-grade dysplasia (0.8% vs 0.7%), sessile serrated lesions (3.52% vs 2.4%), advanced colorectal neoplasia (9.2% vs 7.9%), and colorectal cancer (3.3% vs 3.0%).
However, a prior polypectomy was not independently predictive of colorectal cancer (OR, 0.96; P = .65) or advanced colorectal neoplasia (OR, 0.97; P = .57) in the post-colonoscopy interval FIT.
The findings underscore that “positive results carried a high risk of advanced neoplasia or cancer, irrespective of prior polypectomy history,” Wilson said.
Clinicians Must ‘Do a Better Job’
Commenting on the study, William D. Chey, MD, AGAF, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, noted that the study “addresses one of the biggest challenges we face as a profession, which is making sure that patients who have a positive stool test get a colonoscopy.”
He noted that the low rate of just 50% of recipients of positive FITs going on to receive a colonoscopy is consistent with what is observed in other trials.
“Other data suggests that the rate might even be significantly higher — at 70%-80%, depending upon the population and the test,” Chey told Medscape Medical News.
Reasons for the failure to receive the follow-up testing range from income restrictions (due to the high cost of a colonoscopy, especially if not covered by insurance), education, speaking a foreign language, and other factors, he said.
The relatively high rates of colon cancers detected by FIT in the study, in those with and without a prior polypectomy, along with findings from other studies “should raise questions about whether there might be a role for FIT testing in addition to colonoscopy.” However, much stronger evidence would be needed, Chey noted.
In the meantime, a key issue is “how do we do a better job of making sure that individuals who have a positive FIT test get a colonoscopy,” he said.
“I think a lot of this is going to come down to how it’s done at the primary care level.”
Chey added that in that, and any other setting, “the main message that needs to get out to people who are undergoing stool-based screening is that the stool test is only the first part of the screening process, and if it’s positive, a follow-up colonoscopy must be performed.”
“Otherwise, the stool-based test is of no value.”
Wilson had no disclosures to report. Chey’s disclosures included consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestlé, Phathom, Redhill, Salix/Valeant, Takeda, and Vibrant.
A version of this article appeared on Medscape.com .
FROM ACG 2025