From the AGA Journals

Automated software for calculating adenoma detection rate (ADR) and other colonoscopy performance metrics could expedite the quality review process and open doors to new benchmarks, according to investigators.

The new software, which automatically integrates endoscopy and pathology reports across a variety of practice settings, delivered an ADR on par with manual review, supporting its accuracy and feasibility for real-world usage, reported Todd A. Brenner, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“ADR calculation is resource-intensive, often requiring manual collation of endoscopy and pathology data across multiple reporting modalities, making it an impractical tool for frequent quality audits at many centers,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Although others have tried to streamline ADR calculation, most efforts have relied upon manual entry of pathology data, while approaches using artificial intelligence tend to be costly and clumsy to implement across different databases, according to the investigators.

“Thus, there is a substantial demand for a novel tool to extract and analyze colonoscopy indicators from text-based reports that provides accurate data extraction in a package that is easily implemented and modified by clinicians,” they wrote.

Dr. Brenner and colleagues developed a web-based platform to meet these goals.

Following colonoscopy, the system gathers procedural and histopathology results, extracts and classifies relevant data, then outputs ADR, along with cecal intubation rate, Boston Bowel Preparation Score (BBPS), and withdrawal time.

The software was evaluated using endoscopy and pathology reports from 3,809 colonoscopies performed at six centers over 3 months. Six months later, the investigators manually reviewed data from a validation cohort of 1384 colonoscopies conducted over a 1-month period.

Comparing the automated versus manual approach revealed high congruity, with an ADR of 45.1% for the automated system vs 44.3% for manual review. The software also correctly identified most ADR-qualifying screening colonoscopies (sensitivity, 0.918; specificity, 1.0).

“The discrepancy between manual and automated ADR calculations was exclusively attributable to missed (i.e., false negative) identification of ADR-qualifying procedures,” the investigators wrote.

Of these 43 mislabeled cases, about half involved pending pathology results or erroneous pathology sample entries, while the remainder were due to spelling and/or syntax issues that stumped the system.

Still, Dr. Brenner and colleagues suggested that additional programming can overcome these kinds of issues and allow for generalizability across institutions. They noted that search terms can be edited to match local practice patterns, while the web-based reporting platform can be customized to deliver desired quality metrics.

The publication includes a screenshot of one such dashboard, including a readout of ADR, a comparison of ADR across sexes, a pie chart of BBPS score distribution, and gauge charts for cecal intubation rate and mean withdrawal time.

“Further development of this Internet-based colonoscopy quality reporting platform will focus on integrating additional metrics, such as adenomas per colonoscopy, as well as novel metrics, such as a size-stratified ADR, location-stratified ADR, or ADR stratified by polyp histology,” the investigators wrote.

They predicted that automating data collection in this way could help determine which metrics provide clinically meaningful insights, potentially expanding the roster of standard performance benchmarks.

“We further intend to study the integration of this platform into colonoscopy quality improvement and transparency programs to better characterize the impact of frequent, on-demand ADR feedback on colonoscopy performance,” Dr. Brenner and colleagues concluded.The investigators disclosed relationships with Olympus, Medtronic, Apollo Endosurgery, and others.

Automated software for calculating adenoma detection rate (ADR) and other colonoscopy performance metrics could expedite the quality review process and open doors to new benchmarks, according to investigators.

The new software, which automatically integrates endoscopy and pathology reports across a variety of practice settings, delivered an ADR on par with manual review, supporting its accuracy and feasibility for real-world usage, reported Todd A. Brenner, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“ADR calculation is resource-intensive, often requiring manual collation of endoscopy and pathology data across multiple reporting modalities, making it an impractical tool for frequent quality audits at many centers,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Although others have tried to streamline ADR calculation, most efforts have relied upon manual entry of pathology data, while approaches using artificial intelligence tend to be costly and clumsy to implement across different databases, according to the investigators.

“Thus, there is a substantial demand for a novel tool to extract and analyze colonoscopy indicators from text-based reports that provides accurate data extraction in a package that is easily implemented and modified by clinicians,” they wrote.

Dr. Brenner and colleagues developed a web-based platform to meet these goals.

Following colonoscopy, the system gathers procedural and histopathology results, extracts and classifies relevant data, then outputs ADR, along with cecal intubation rate, Boston Bowel Preparation Score (BBPS), and withdrawal time.

The software was evaluated using endoscopy and pathology reports from 3,809 colonoscopies performed at six centers over 3 months. Six months later, the investigators manually reviewed data from a validation cohort of 1384 colonoscopies conducted over a 1-month period.

Comparing the automated versus manual approach revealed high congruity, with an ADR of 45.1% for the automated system vs 44.3% for manual review. The software also correctly identified most ADR-qualifying screening colonoscopies (sensitivity, 0.918; specificity, 1.0).

“The discrepancy between manual and automated ADR calculations was exclusively attributable to missed (i.e., false negative) identification of ADR-qualifying procedures,” the investigators wrote.

Of these 43 mislabeled cases, about half involved pending pathology results or erroneous pathology sample entries, while the remainder were due to spelling and/or syntax issues that stumped the system.

Still, Dr. Brenner and colleagues suggested that additional programming can overcome these kinds of issues and allow for generalizability across institutions. They noted that search terms can be edited to match local practice patterns, while the web-based reporting platform can be customized to deliver desired quality metrics.

The publication includes a screenshot of one such dashboard, including a readout of ADR, a comparison of ADR across sexes, a pie chart of BBPS score distribution, and gauge charts for cecal intubation rate and mean withdrawal time.

“Further development of this Internet-based colonoscopy quality reporting platform will focus on integrating additional metrics, such as adenomas per colonoscopy, as well as novel metrics, such as a size-stratified ADR, location-stratified ADR, or ADR stratified by polyp histology,” the investigators wrote.

They predicted that automating data collection in this way could help determine which metrics provide clinically meaningful insights, potentially expanding the roster of standard performance benchmarks.

“We further intend to study the integration of this platform into colonoscopy quality improvement and transparency programs to better characterize the impact of frequent, on-demand ADR feedback on colonoscopy performance,” Dr. Brenner and colleagues concluded.The investigators disclosed relationships with Olympus, Medtronic, Apollo Endosurgery, and others.

Automated software for calculating adenoma detection rate (ADR) and other colonoscopy performance metrics could expedite the quality review process and open doors to new benchmarks, according to investigators.

The new software, which automatically integrates endoscopy and pathology reports across a variety of practice settings, delivered an ADR on par with manual review, supporting its accuracy and feasibility for real-world usage, reported Todd A. Brenner, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“ADR calculation is resource-intensive, often requiring manual collation of endoscopy and pathology data across multiple reporting modalities, making it an impractical tool for frequent quality audits at many centers,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Although others have tried to streamline ADR calculation, most efforts have relied upon manual entry of pathology data, while approaches using artificial intelligence tend to be costly and clumsy to implement across different databases, according to the investigators.

“Thus, there is a substantial demand for a novel tool to extract and analyze colonoscopy indicators from text-based reports that provides accurate data extraction in a package that is easily implemented and modified by clinicians,” they wrote.

Dr. Brenner and colleagues developed a web-based platform to meet these goals.

Following colonoscopy, the system gathers procedural and histopathology results, extracts and classifies relevant data, then outputs ADR, along with cecal intubation rate, Boston Bowel Preparation Score (BBPS), and withdrawal time.

The software was evaluated using endoscopy and pathology reports from 3,809 colonoscopies performed at six centers over 3 months. Six months later, the investigators manually reviewed data from a validation cohort of 1384 colonoscopies conducted over a 1-month period.

Comparing the automated versus manual approach revealed high congruity, with an ADR of 45.1% for the automated system vs 44.3% for manual review. The software also correctly identified most ADR-qualifying screening colonoscopies (sensitivity, 0.918; specificity, 1.0).

“The discrepancy between manual and automated ADR calculations was exclusively attributable to missed (i.e., false negative) identification of ADR-qualifying procedures,” the investigators wrote.

Of these 43 mislabeled cases, about half involved pending pathology results or erroneous pathology sample entries, while the remainder were due to spelling and/or syntax issues that stumped the system.

Still, Dr. Brenner and colleagues suggested that additional programming can overcome these kinds of issues and allow for generalizability across institutions. They noted that search terms can be edited to match local practice patterns, while the web-based reporting platform can be customized to deliver desired quality metrics.

The publication includes a screenshot of one such dashboard, including a readout of ADR, a comparison of ADR across sexes, a pie chart of BBPS score distribution, and gauge charts for cecal intubation rate and mean withdrawal time.

“Further development of this Internet-based colonoscopy quality reporting platform will focus on integrating additional metrics, such as adenomas per colonoscopy, as well as novel metrics, such as a size-stratified ADR, location-stratified ADR, or ADR stratified by polyp histology,” the investigators wrote.

They predicted that automating data collection in this way could help determine which metrics provide clinically meaningful insights, potentially expanding the roster of standard performance benchmarks.

“We further intend to study the integration of this platform into colonoscopy quality improvement and transparency programs to better characterize the impact of frequent, on-demand ADR feedback on colonoscopy performance,” Dr. Brenner and colleagues concluded.The investigators disclosed relationships with Olympus, Medtronic, Apollo Endosurgery, and others.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with a host of negative clinical outcomes across cardiovascular, metabolic, and oncologic domains, based on a large-scale meta-analysis of longitudinal data.

These findings emphasize the multisystemic nature of MASLD, suggesting that broader treatment targets are needed to reduce systemic events and end organ complications, reported lead author Kai En Chan, MBBS, of the National University of Singapore, and colleagues.

“[D]espite the substantial impact of MASLD, with direct medical costs estimated to reach $103 billion in the United States alone, a comprehensive umbrella meta-analysis of the longitudinal complications associated with MASLD has yet to be conducted,” the investigators wrote in Clinical Gastroenterology and Hepatology, noting that key outcomes associated with sex and disease severity have yet to be elucidated. “A comprehensive understanding of the spectrum of clinical complications associated with MASLD is thus crucial in developing effective disease management strategies and optimizing the allocation of limited healthcare resources.”

To this end, the investigators analyzed data from 129 studies reporting longitudinal risks of clinical outcomes among adults with MASLD. Assessed complications spanned a broad array of organ systems and pathologies. Cardiovascular and oncologic conditions predominated, while chronic kidney disease, liver-related outcomes, gallstone formation, dementia, and reflux esophagitis were also considered.

The analysis revealed significant associations between MASLD and — in ascending level of risk — chronic kidney disease (hazard ratio [HR], 1.38), cardiovascular diseases (HR, 1.43), cancer (HR, 1.54), prediabetes (HR, 1.69), hypertension (HR, 1.75), diabetes (HR, 2.56), and metabolic syndrome (HR, 2.57).

Across cardiovascular diseases, MASLD raised risk of hypertension the most, by 75%. Among cancer types, MASLD increased risk of hepatocellular carcinoma to the greatest degree, by more than fourfold.

No significant sex-specific differences in MASLD-associated risk were detected for cancer, chronic kidney disease, diabetes, or cardiovascular disease, although the investigators urged a cautious interpretation of these findings, since relevant data were scarce.

“It is imperative to understand that MASLD is a complex and multifaceted condition that requires a comprehensive approach to recognition and treatment beyond that of the hepatologist alone,” the investigators wrote.

They also suggested that the link between MASLD and cancer deserves particular attention.

“Although the mechanism by which MASLD gives rise to cardiovascular disease and diabetes has been thoroughly researched, the pathophysiology of MASLD leading to extrahepatic carcinogenesis is less well understood and has been postulated to be linked to chronic inflammation and dysregulation of the gut microbiome in MASLD,” they wrote.

Lastly, considering the multiprong association between MASLD and so many complications, the investigators recommended broader clinical metrics for measuring outcomes in patients with MASLD.

“With the synergistic increases of metabolic diseases globally, treatment targets should in turn act beyond the resolution of fibrosis but also to reduce systemic end organ complications,” they concluded.The investigators disclosed relationships with AbbVie, Echosens, Gilead Sciences, and others.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with a host of negative clinical outcomes across cardiovascular, metabolic, and oncologic domains, based on a large-scale meta-analysis of longitudinal data.

These findings emphasize the multisystemic nature of MASLD, suggesting that broader treatment targets are needed to reduce systemic events and end organ complications, reported lead author Kai En Chan, MBBS, of the National University of Singapore, and colleagues.

“[D]espite the substantial impact of MASLD, with direct medical costs estimated to reach $103 billion in the United States alone, a comprehensive umbrella meta-analysis of the longitudinal complications associated with MASLD has yet to be conducted,” the investigators wrote in Clinical Gastroenterology and Hepatology, noting that key outcomes associated with sex and disease severity have yet to be elucidated. “A comprehensive understanding of the spectrum of clinical complications associated with MASLD is thus crucial in developing effective disease management strategies and optimizing the allocation of limited healthcare resources.”

To this end, the investigators analyzed data from 129 studies reporting longitudinal risks of clinical outcomes among adults with MASLD. Assessed complications spanned a broad array of organ systems and pathologies. Cardiovascular and oncologic conditions predominated, while chronic kidney disease, liver-related outcomes, gallstone formation, dementia, and reflux esophagitis were also considered.

The analysis revealed significant associations between MASLD and — in ascending level of risk — chronic kidney disease (hazard ratio [HR], 1.38), cardiovascular diseases (HR, 1.43), cancer (HR, 1.54), prediabetes (HR, 1.69), hypertension (HR, 1.75), diabetes (HR, 2.56), and metabolic syndrome (HR, 2.57).

Across cardiovascular diseases, MASLD raised risk of hypertension the most, by 75%. Among cancer types, MASLD increased risk of hepatocellular carcinoma to the greatest degree, by more than fourfold.

No significant sex-specific differences in MASLD-associated risk were detected for cancer, chronic kidney disease, diabetes, or cardiovascular disease, although the investigators urged a cautious interpretation of these findings, since relevant data were scarce.

“It is imperative to understand that MASLD is a complex and multifaceted condition that requires a comprehensive approach to recognition and treatment beyond that of the hepatologist alone,” the investigators wrote.

They also suggested that the link between MASLD and cancer deserves particular attention.

“Although the mechanism by which MASLD gives rise to cardiovascular disease and diabetes has been thoroughly researched, the pathophysiology of MASLD leading to extrahepatic carcinogenesis is less well understood and has been postulated to be linked to chronic inflammation and dysregulation of the gut microbiome in MASLD,” they wrote.

Lastly, considering the multiprong association between MASLD and so many complications, the investigators recommended broader clinical metrics for measuring outcomes in patients with MASLD.

“With the synergistic increases of metabolic diseases globally, treatment targets should in turn act beyond the resolution of fibrosis but also to reduce systemic end organ complications,” they concluded.The investigators disclosed relationships with AbbVie, Echosens, Gilead Sciences, and others.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with a host of negative clinical outcomes across cardiovascular, metabolic, and oncologic domains, based on a large-scale meta-analysis of longitudinal data.

These findings emphasize the multisystemic nature of MASLD, suggesting that broader treatment targets are needed to reduce systemic events and end organ complications, reported lead author Kai En Chan, MBBS, of the National University of Singapore, and colleagues.

“[D]espite the substantial impact of MASLD, with direct medical costs estimated to reach $103 billion in the United States alone, a comprehensive umbrella meta-analysis of the longitudinal complications associated with MASLD has yet to be conducted,” the investigators wrote in Clinical Gastroenterology and Hepatology, noting that key outcomes associated with sex and disease severity have yet to be elucidated. “A comprehensive understanding of the spectrum of clinical complications associated with MASLD is thus crucial in developing effective disease management strategies and optimizing the allocation of limited healthcare resources.”

To this end, the investigators analyzed data from 129 studies reporting longitudinal risks of clinical outcomes among adults with MASLD. Assessed complications spanned a broad array of organ systems and pathologies. Cardiovascular and oncologic conditions predominated, while chronic kidney disease, liver-related outcomes, gallstone formation, dementia, and reflux esophagitis were also considered.

The analysis revealed significant associations between MASLD and — in ascending level of risk — chronic kidney disease (hazard ratio [HR], 1.38), cardiovascular diseases (HR, 1.43), cancer (HR, 1.54), prediabetes (HR, 1.69), hypertension (HR, 1.75), diabetes (HR, 2.56), and metabolic syndrome (HR, 2.57).

Across cardiovascular diseases, MASLD raised risk of hypertension the most, by 75%. Among cancer types, MASLD increased risk of hepatocellular carcinoma to the greatest degree, by more than fourfold.

No significant sex-specific differences in MASLD-associated risk were detected for cancer, chronic kidney disease, diabetes, or cardiovascular disease, although the investigators urged a cautious interpretation of these findings, since relevant data were scarce.

“It is imperative to understand that MASLD is a complex and multifaceted condition that requires a comprehensive approach to recognition and treatment beyond that of the hepatologist alone,” the investigators wrote.

They also suggested that the link between MASLD and cancer deserves particular attention.

“Although the mechanism by which MASLD gives rise to cardiovascular disease and diabetes has been thoroughly researched, the pathophysiology of MASLD leading to extrahepatic carcinogenesis is less well understood and has been postulated to be linked to chronic inflammation and dysregulation of the gut microbiome in MASLD,” they wrote.

Lastly, considering the multiprong association between MASLD and so many complications, the investigators recommended broader clinical metrics for measuring outcomes in patients with MASLD.

“With the synergistic increases of metabolic diseases globally, treatment targets should in turn act beyond the resolution of fibrosis but also to reduce systemic end organ complications,” they concluded.The investigators disclosed relationships with AbbVie, Echosens, Gilead Sciences, and others.

American Gastroenterological Association (AGA) has published a clinical practice update on endoscopic full-thickness resection (EFTR) for the management of gastrointestinal subepithelial lesions (SELs).

The new guidance document, authored by Lionel S. D’Souza, MD, of Stony Brook University Hospital, Stony Brook, New York, and colleagues, offers a framework for deciding between various EFTR techniques based on lesion histology, size, and location.

“EFTR has emerged as a novel treatment option for select SELs,” the update panelists wrote in Gastroenterology. “In this commentary, we reviewed the different techniques and uses of EFTR for the management of SELs.”

They noted that all patients with SELs should first undergo multidisciplinary evaluation in accordance with a separate AGA guidance document on SELs.

The present update focuses specifically on EFTR, first by distinguishing between exposed and nonexposed techniques. While the former involves resection of the mucosa and all other layers of the wall, the latter relies upon a ‘close first, then cut’ method to prevent perforation, or preservation of an overlying flap of mucosa.

The new guidance calls for a nonexposed technique unless the exposed approach is necessary.

“In our opinion, the exposed EFTR technique should be considered for lesions in which other methods (i.e., endoscopic mucosal resection, endoscopic submucosal dissection, and nonexposed EFTR) cannot reliably and completely excise SELs due to larger size or difficult location of the lesion,” the update panelists wrote. “The exposed EFTR technique may be best suited for gastric lesions and as an alternative to other endoscopic approaches for SELs in the rectum. The exposed technique should be avoided in the esophagus and duodenum, as the clinical consequences of a leak can be devastating and endoscopic closure is notoriously challenging.”

Dr. D’Souza and colleagues went on to discuss various nonexposed techniques, including submucosal tunneling and endoscopic resection and peroral endoscopic tunnel resection (STER/POET), device-assisted endoscopic full-thickness resection, and full-thickness resection with an over-the-scope clip with integrated snare (FTRD).

They highlighted how STER/POET encourages traction on the lesion and scope stability while limiting extravasation of luminal contents, and closure tends to be easier than with exposed EFTR. This approach should be reserved for tumors smaller than approximately 3-4 cm, however, with the update noting that lesions larger than 2 cm may present increased risk of incomplete resection. Similarly, device-assisted endoscopic full-thickness resection, which involves pulling or suctioning the lesion into the device, is also limited by lesion size, although fewer data are available to guide size thresholds.

FTRD, which involves “a 23-mm deep cap with a specially designed over-the-scope clip and integrated cautery snare,” also lacks a broad evidence base.

“Although there has been reasonable clinical success reported in most case series, several factors should be considered with the use of the FTRD for SELs,” the update cautions.

Specifically, a recent Dutch and German registry study of FTRD had an adverse event rate of 11.3%, with an approximate 1% perforation rate. More than half of the perforations were due to technical or procedural issues.

“This adverse event rate may improve as individual experience with the device is gained; however, data on this are lacking,” the panelists wrote, also noting that lesions 1.5 cm or larger may carry a higher risk of incomplete resection.

Ultimately, the clinical practice update calls for a personalized approach to EFTR decision-making that considers factors extending beyond the lesion.

“The ‘ideal’ technique will depend on various patient and lesion characteristics, as well as the endoscopist’s preference and available expertise,” Dr. D’Souza and colleagues concluded. “Further research into the efficacy of these resection techniques and the long-term outcomes in patients after endoscopic resection of SELs will be essential in standardizing appropriate resection algorithms.”

This clinical practice update was commissioned and approved by AGA Institute. The investigators disclosed relationships with Olympus, Fujifilm, Apollo Endosurgery, and others.

American Gastroenterological Association (AGA) has published a clinical practice update on endoscopic full-thickness resection (EFTR) for the management of gastrointestinal subepithelial lesions (SELs).

The new guidance document, authored by Lionel S. D’Souza, MD, of Stony Brook University Hospital, Stony Brook, New York, and colleagues, offers a framework for deciding between various EFTR techniques based on lesion histology, size, and location.

“EFTR has emerged as a novel treatment option for select SELs,” the update panelists wrote in Gastroenterology. “In this commentary, we reviewed the different techniques and uses of EFTR for the management of SELs.”

They noted that all patients with SELs should first undergo multidisciplinary evaluation in accordance with a separate AGA guidance document on SELs.

The present update focuses specifically on EFTR, first by distinguishing between exposed and nonexposed techniques. While the former involves resection of the mucosa and all other layers of the wall, the latter relies upon a ‘close first, then cut’ method to prevent perforation, or preservation of an overlying flap of mucosa.

The new guidance calls for a nonexposed technique unless the exposed approach is necessary.

“In our opinion, the exposed EFTR technique should be considered for lesions in which other methods (i.e., endoscopic mucosal resection, endoscopic submucosal dissection, and nonexposed EFTR) cannot reliably and completely excise SELs due to larger size or difficult location of the lesion,” the update panelists wrote. “The exposed EFTR technique may be best suited for gastric lesions and as an alternative to other endoscopic approaches for SELs in the rectum. The exposed technique should be avoided in the esophagus and duodenum, as the clinical consequences of a leak can be devastating and endoscopic closure is notoriously challenging.”

Dr. D’Souza and colleagues went on to discuss various nonexposed techniques, including submucosal tunneling and endoscopic resection and peroral endoscopic tunnel resection (STER/POET), device-assisted endoscopic full-thickness resection, and full-thickness resection with an over-the-scope clip with integrated snare (FTRD).

They highlighted how STER/POET encourages traction on the lesion and scope stability while limiting extravasation of luminal contents, and closure tends to be easier than with exposed EFTR. This approach should be reserved for tumors smaller than approximately 3-4 cm, however, with the update noting that lesions larger than 2 cm may present increased risk of incomplete resection. Similarly, device-assisted endoscopic full-thickness resection, which involves pulling or suctioning the lesion into the device, is also limited by lesion size, although fewer data are available to guide size thresholds.

FTRD, which involves “a 23-mm deep cap with a specially designed over-the-scope clip and integrated cautery snare,” also lacks a broad evidence base.

“Although there has been reasonable clinical success reported in most case series, several factors should be considered with the use of the FTRD for SELs,” the update cautions.

Specifically, a recent Dutch and German registry study of FTRD had an adverse event rate of 11.3%, with an approximate 1% perforation rate. More than half of the perforations were due to technical or procedural issues.

“This adverse event rate may improve as individual experience with the device is gained; however, data on this are lacking,” the panelists wrote, also noting that lesions 1.5 cm or larger may carry a higher risk of incomplete resection.

Ultimately, the clinical practice update calls for a personalized approach to EFTR decision-making that considers factors extending beyond the lesion.

“The ‘ideal’ technique will depend on various patient and lesion characteristics, as well as the endoscopist’s preference and available expertise,” Dr. D’Souza and colleagues concluded. “Further research into the efficacy of these resection techniques and the long-term outcomes in patients after endoscopic resection of SELs will be essential in standardizing appropriate resection algorithms.”

This clinical practice update was commissioned and approved by AGA Institute. The investigators disclosed relationships with Olympus, Fujifilm, Apollo Endosurgery, and others.

American Gastroenterological Association (AGA) has published a clinical practice update on endoscopic full-thickness resection (EFTR) for the management of gastrointestinal subepithelial lesions (SELs).

The new guidance document, authored by Lionel S. D’Souza, MD, of Stony Brook University Hospital, Stony Brook, New York, and colleagues, offers a framework for deciding between various EFTR techniques based on lesion histology, size, and location.

“EFTR has emerged as a novel treatment option for select SELs,” the update panelists wrote in Gastroenterology. “In this commentary, we reviewed the different techniques and uses of EFTR for the management of SELs.”

They noted that all patients with SELs should first undergo multidisciplinary evaluation in accordance with a separate AGA guidance document on SELs.

The present update focuses specifically on EFTR, first by distinguishing between exposed and nonexposed techniques. While the former involves resection of the mucosa and all other layers of the wall, the latter relies upon a ‘close first, then cut’ method to prevent perforation, or preservation of an overlying flap of mucosa.

The new guidance calls for a nonexposed technique unless the exposed approach is necessary.

“In our opinion, the exposed EFTR technique should be considered for lesions in which other methods (i.e., endoscopic mucosal resection, endoscopic submucosal dissection, and nonexposed EFTR) cannot reliably and completely excise SELs due to larger size or difficult location of the lesion,” the update panelists wrote. “The exposed EFTR technique may be best suited for gastric lesions and as an alternative to other endoscopic approaches for SELs in the rectum. The exposed technique should be avoided in the esophagus and duodenum, as the clinical consequences of a leak can be devastating and endoscopic closure is notoriously challenging.”

Dr. D’Souza and colleagues went on to discuss various nonexposed techniques, including submucosal tunneling and endoscopic resection and peroral endoscopic tunnel resection (STER/POET), device-assisted endoscopic full-thickness resection, and full-thickness resection with an over-the-scope clip with integrated snare (FTRD).

They highlighted how STER/POET encourages traction on the lesion and scope stability while limiting extravasation of luminal contents, and closure tends to be easier than with exposed EFTR. This approach should be reserved for tumors smaller than approximately 3-4 cm, however, with the update noting that lesions larger than 2 cm may present increased risk of incomplete resection. Similarly, device-assisted endoscopic full-thickness resection, which involves pulling or suctioning the lesion into the device, is also limited by lesion size, although fewer data are available to guide size thresholds.

FTRD, which involves “a 23-mm deep cap with a specially designed over-the-scope clip and integrated cautery snare,” also lacks a broad evidence base.

“Although there has been reasonable clinical success reported in most case series, several factors should be considered with the use of the FTRD for SELs,” the update cautions.

Specifically, a recent Dutch and German registry study of FTRD had an adverse event rate of 11.3%, with an approximate 1% perforation rate. More than half of the perforations were due to technical or procedural issues.

“This adverse event rate may improve as individual experience with the device is gained; however, data on this are lacking,” the panelists wrote, also noting that lesions 1.5 cm or larger may carry a higher risk of incomplete resection.

Ultimately, the clinical practice update calls for a personalized approach to EFTR decision-making that considers factors extending beyond the lesion.

“The ‘ideal’ technique will depend on various patient and lesion characteristics, as well as the endoscopist’s preference and available expertise,” Dr. D’Souza and colleagues concluded. “Further research into the efficacy of these resection techniques and the long-term outcomes in patients after endoscopic resection of SELs will be essential in standardizing appropriate resection algorithms.”

This clinical practice update was commissioned and approved by AGA Institute. The investigators disclosed relationships with Olympus, Fujifilm, Apollo Endosurgery, and others.

Telephone outreach and secure messaging have better response rates than mailed letters when it comes to communicating updated colonoscopy intervals for patients with a history of low-risk adenomas, a randomized trial found.

In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:

• Telephone: 64.5%
• Secure messaging: 51.7%
• Mailed letter: 31.3%

Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).

Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.

Kaiser Permanente Medical Center

The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).

In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.

Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).

Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.

“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”

“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.

More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.

With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
 

Study Details

The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.

As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”

But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
 

Downsides to Retroactive Changes?

Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.

Baylor College of Medicine

“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.

Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.

Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”

Northwell Health

While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”

As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.”  Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.

The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.

The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.

Telephone outreach and secure messaging have better response rates than mailed letters when it comes to communicating updated colonoscopy intervals for patients with a history of low-risk adenomas, a randomized trial found.

In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:

• Telephone: 64.5%
• Secure messaging: 51.7%
• Mailed letter: 31.3%

Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).

Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.

Kaiser Permanente Medical Center

The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).

In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.

Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).

Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.

“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”

“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.

More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.

With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
 

Study Details

The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.

As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”

But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
 

Downsides to Retroactive Changes?

Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.

Baylor College of Medicine

“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.

Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.

Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”

Northwell Health

While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”

As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.”  Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.

The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.

The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.

Telephone outreach and secure messaging have better response rates than mailed letters when it comes to communicating updated colonoscopy intervals for patients with a history of low-risk adenomas, a randomized trial found.

In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:

• Telephone: 64.5%
• Secure messaging: 51.7%
• Mailed letter: 31.3%

Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).

Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.

Kaiser Permanente Medical Center

The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).

In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.

Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).

Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.

“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”

“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.

More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.

With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
 

Study Details

The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.

As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”

But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
 

Downsides to Retroactive Changes?

Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.

Baylor College of Medicine

“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.

Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.

Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”

Northwell Health

While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”

As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.”  Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.

The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.

The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.

South Korea’s gastric cancer screening (GC) program has reduced disease-related mortality by 41%.

Japan’s? Not at all.

These findings suggest that the benefits of nationwide gastric cancer screening may vary widely between countries while offering insights into program best practices, reported lead author Dianqin Sun, a PhD candidate at the University Medical Center, Rotterdam, the Netherlands, and colleagues.

Mr. Sun

“Despite the lack of evidence from randomized controlled trials, South Korea and Japan, two countries with a high GC incidence, have been at the forefront of GC secondary prevention and have implemented nationwide organized GC screening programs for decades using endoscopy or upper gastrointestinal series,” the investigators wrote in Gastroenterology.

Although individual-level data from both programs supports their efficacy in reducing GC-related death, the investigators noted that these studies have been limited by volunteer bias, and population-level data remain scarce.

To address this knowledge gap, Mr. Sun and colleagues used the flexible synthetic control method to determine how screening programs affected GC mortality rate, as well as a composite mortality rate for esophageal cancer and peptic ulcer.

“The concept of the synthetic control method is to construct a synthetic control for the treated country by deriving a weighted average of multiple control countries without intervention,” the investigators wrote. “The weight of controls is determined in a data-driven way to minimize the differences in preintervention outcomes (i.e., GC mortality before the introduction of nationwide screening) and other covariates associated with GC mortality between the treated country and the synthetic control.”

This approach revealed starkly different benefits for South Korea and Japan.

Compared with the synthetic control, South Korea’s screening program was associated with a 17% reduction in GC mortality risk on average, with risk dropping as far as 41% after the 15th year of screening. The Korean program was also associated with a 28% reduction in mortality from esophageal cancer and peptic ulcer, with this rate decreasing as much as 53% after 15 years of screening.

In sharp contrast, Japan’s mortality rates for GC and the other GI diseases were not significantly different from the synthetic control after 34 years of screening.

The investigators suggested several possible factors behind the lack of benefit in Japan, including the absence of a recommendation for endoscopic screening until 2014. In 2015, just 19% of municipalities in Japan were using endoscopy for screening, compared with more than 72% in South Korea in 2011. Furthermore, guideline adherence and screening program adherence are lower in Japan, they noted.

“Therefore, the findings in our study may have been expected,” the investigators wrote. “However, it is important to note that certain covariates were unavailable for the analysis in Japan, which may have introduced potential biases, the directions of which are unclear. Further studies are needed to compare the screening impact in South Korea and Japan.”

Meanwhile, the present results could guide screening programs around the world, Mr. Sun and colleagues suggested.

“This [study] highlights the significance of a well-planned organizational structure and evidence-based decision making when organized screening is started,” they wrote. “With a quasi-experimental design, this study will facilitate triangulating current observational evidence and provide valuable insights while the GC screening randomized controlled trials are still underway. The data and experience from South Korea and Japan will inform GC screening policy in other countries.”

The investigators disclosed no conflicts of interest.

South Korea’s gastric cancer screening (GC) program has reduced disease-related mortality by 41%.

Japan’s? Not at all.

These findings suggest that the benefits of nationwide gastric cancer screening may vary widely between countries while offering insights into program best practices, reported lead author Dianqin Sun, a PhD candidate at the University Medical Center, Rotterdam, the Netherlands, and colleagues.

Mr. Sun

“Despite the lack of evidence from randomized controlled trials, South Korea and Japan, two countries with a high GC incidence, have been at the forefront of GC secondary prevention and have implemented nationwide organized GC screening programs for decades using endoscopy or upper gastrointestinal series,” the investigators wrote in Gastroenterology.

Although individual-level data from both programs supports their efficacy in reducing GC-related death, the investigators noted that these studies have been limited by volunteer bias, and population-level data remain scarce.

To address this knowledge gap, Mr. Sun and colleagues used the flexible synthetic control method to determine how screening programs affected GC mortality rate, as well as a composite mortality rate for esophageal cancer and peptic ulcer.

“The concept of the synthetic control method is to construct a synthetic control for the treated country by deriving a weighted average of multiple control countries without intervention,” the investigators wrote. “The weight of controls is determined in a data-driven way to minimize the differences in preintervention outcomes (i.e., GC mortality before the introduction of nationwide screening) and other covariates associated with GC mortality between the treated country and the synthetic control.”

This approach revealed starkly different benefits for South Korea and Japan.

Compared with the synthetic control, South Korea’s screening program was associated with a 17% reduction in GC mortality risk on average, with risk dropping as far as 41% after the 15th year of screening. The Korean program was also associated with a 28% reduction in mortality from esophageal cancer and peptic ulcer, with this rate decreasing as much as 53% after 15 years of screening.

In sharp contrast, Japan’s mortality rates for GC and the other GI diseases were not significantly different from the synthetic control after 34 years of screening.

The investigators suggested several possible factors behind the lack of benefit in Japan, including the absence of a recommendation for endoscopic screening until 2014. In 2015, just 19% of municipalities in Japan were using endoscopy for screening, compared with more than 72% in South Korea in 2011. Furthermore, guideline adherence and screening program adherence are lower in Japan, they noted.

“Therefore, the findings in our study may have been expected,” the investigators wrote. “However, it is important to note that certain covariates were unavailable for the analysis in Japan, which may have introduced potential biases, the directions of which are unclear. Further studies are needed to compare the screening impact in South Korea and Japan.”

Meanwhile, the present results could guide screening programs around the world, Mr. Sun and colleagues suggested.

“This [study] highlights the significance of a well-planned organizational structure and evidence-based decision making when organized screening is started,” they wrote. “With a quasi-experimental design, this study will facilitate triangulating current observational evidence and provide valuable insights while the GC screening randomized controlled trials are still underway. The data and experience from South Korea and Japan will inform GC screening policy in other countries.”

The investigators disclosed no conflicts of interest.

South Korea’s gastric cancer screening (GC) program has reduced disease-related mortality by 41%.

Japan’s? Not at all.

These findings suggest that the benefits of nationwide gastric cancer screening may vary widely between countries while offering insights into program best practices, reported lead author Dianqin Sun, a PhD candidate at the University Medical Center, Rotterdam, the Netherlands, and colleagues.

Mr. Sun

“Despite the lack of evidence from randomized controlled trials, South Korea and Japan, two countries with a high GC incidence, have been at the forefront of GC secondary prevention and have implemented nationwide organized GC screening programs for decades using endoscopy or upper gastrointestinal series,” the investigators wrote in Gastroenterology.

Although individual-level data from both programs supports their efficacy in reducing GC-related death, the investigators noted that these studies have been limited by volunteer bias, and population-level data remain scarce.

To address this knowledge gap, Mr. Sun and colleagues used the flexible synthetic control method to determine how screening programs affected GC mortality rate, as well as a composite mortality rate for esophageal cancer and peptic ulcer.

“The concept of the synthetic control method is to construct a synthetic control for the treated country by deriving a weighted average of multiple control countries without intervention,” the investigators wrote. “The weight of controls is determined in a data-driven way to minimize the differences in preintervention outcomes (i.e., GC mortality before the introduction of nationwide screening) and other covariates associated with GC mortality between the treated country and the synthetic control.”

This approach revealed starkly different benefits for South Korea and Japan.

Compared with the synthetic control, South Korea’s screening program was associated with a 17% reduction in GC mortality risk on average, with risk dropping as far as 41% after the 15th year of screening. The Korean program was also associated with a 28% reduction in mortality from esophageal cancer and peptic ulcer, with this rate decreasing as much as 53% after 15 years of screening.

In sharp contrast, Japan’s mortality rates for GC and the other GI diseases were not significantly different from the synthetic control after 34 years of screening.

The investigators suggested several possible factors behind the lack of benefit in Japan, including the absence of a recommendation for endoscopic screening until 2014. In 2015, just 19% of municipalities in Japan were using endoscopy for screening, compared with more than 72% in South Korea in 2011. Furthermore, guideline adherence and screening program adherence are lower in Japan, they noted.

“Therefore, the findings in our study may have been expected,” the investigators wrote. “However, it is important to note that certain covariates were unavailable for the analysis in Japan, which may have introduced potential biases, the directions of which are unclear. Further studies are needed to compare the screening impact in South Korea and Japan.”

Meanwhile, the present results could guide screening programs around the world, Mr. Sun and colleagues suggested.

“This [study] highlights the significance of a well-planned organizational structure and evidence-based decision making when organized screening is started,” they wrote. “With a quasi-experimental design, this study will facilitate triangulating current observational evidence and provide valuable insights while the GC screening randomized controlled trials are still underway. The data and experience from South Korea and Japan will inform GC screening policy in other countries.”

The investigators disclosed no conflicts of interest.

Two species of gut bacteria modulate the immune system and even the survival of one another to impact the progression of chronic hepatitis B (CHB), according to investigators.

While Ruminococcus gnavus promotes immune tolerance and therefore HBV persistence, Akkermansia muciniphila stimulates the immune system, promoting viral clearance, reported lead author Huey-Huey Chua, MD, of the National Taiwan University College of Medicine and Children’s Hospital, Taipei, and colleagues.

These findings could lead to new therapeutic strategies, such as administration of the secretory products of A. muciniphila, or provision of probiotics and prebiotics that tip the balance toward this more beneficial bacterium, the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology.

Their study, which included data from both human patients and mouse models of CHB, was grounded in prior research showing a link between gut microbiota and the age-dependence of HBV immunity.

“Sterilization of the gut microbiota using antibiotics prevents adult mice from rapidly clearing HBV and restores the tolerance phenotype, implying that the gut microbiota may transmit signals to break liver tolerance and evoke rapid HBV clearance,” Dr. Chua and colleagues wrote. “We hypothesized that the wax and wane of gut microbiota signatures may determine the progression of CHB. We aimed to delineate what the pivotal bacteria are and how they manipulate the progression of CHB.”

They began by analyzing fecal samples from 102 patients with CHB either in the immune-tolerant (IT) or immune-active (IA) phase of infection.

R. gnavus was the most abundant species among IT patients, whereas A. muciniphila was most abundant among patients in the IA phase. Higher levels of A. muciniphila were also associated with early hepatitis B e-antigen (HBeAG) loss, HBeAG seroconversion, and flares of aminotransferase. A mouse model echoed these findings.

Further experiments with mouse models revealed that R. gnavus modulates bile acids to promote HBV persistence and prolongation of the IT course. In opposition, A. muciniphila removes cholesterol and secretes metabolites that inhibit growth and function of R. gnavus.

“These novel findings will certainly confer a groundbreaking impact on the future therapy of CHB,” Dr. Chua and colleagues wrote.

They went on to describe several therapeutic strategies worth further investigation.

“A key step to promote switching from the IT to IA phase is to lessen the richness of R. gnavus and bile acid bioconversion from cholesterol,” they wrote. The secretory products of A. muciniphila that successfully ameliorate the burden of R. gnavus outgrowth can be provided as useful means to induce anti-HBV efficacy. Also, the development of targeted probiotics or prebiotics that can modulate the gut microbiota composition to favor the beneficial effects of A. muciniphila while inhibiting the detrimental effects of R. gnavus may have translational value for CHB.”

The study was supported by the Ministry of Science and Technology, Executive Yuan, Taiwan and the Center of Precision Medicine from Featured Areas Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education in Taiwan. The investigators disclosed no conflicts of interest.

Two species of gut bacteria modulate the immune system and even the survival of one another to impact the progression of chronic hepatitis B (CHB), according to investigators.

While Ruminococcus gnavus promotes immune tolerance and therefore HBV persistence, Akkermansia muciniphila stimulates the immune system, promoting viral clearance, reported lead author Huey-Huey Chua, MD, of the National Taiwan University College of Medicine and Children’s Hospital, Taipei, and colleagues.

These findings could lead to new therapeutic strategies, such as administration of the secretory products of A. muciniphila, or provision of probiotics and prebiotics that tip the balance toward this more beneficial bacterium, the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology.

Their study, which included data from both human patients and mouse models of CHB, was grounded in prior research showing a link between gut microbiota and the age-dependence of HBV immunity.

“Sterilization of the gut microbiota using antibiotics prevents adult mice from rapidly clearing HBV and restores the tolerance phenotype, implying that the gut microbiota may transmit signals to break liver tolerance and evoke rapid HBV clearance,” Dr. Chua and colleagues wrote. “We hypothesized that the wax and wane of gut microbiota signatures may determine the progression of CHB. We aimed to delineate what the pivotal bacteria are and how they manipulate the progression of CHB.”

They began by analyzing fecal samples from 102 patients with CHB either in the immune-tolerant (IT) or immune-active (IA) phase of infection.

R. gnavus was the most abundant species among IT patients, whereas A. muciniphila was most abundant among patients in the IA phase. Higher levels of A. muciniphila were also associated with early hepatitis B e-antigen (HBeAG) loss, HBeAG seroconversion, and flares of aminotransferase. A mouse model echoed these findings.

Further experiments with mouse models revealed that R. gnavus modulates bile acids to promote HBV persistence and prolongation of the IT course. In opposition, A. muciniphila removes cholesterol and secretes metabolites that inhibit growth and function of R. gnavus.

“These novel findings will certainly confer a groundbreaking impact on the future therapy of CHB,” Dr. Chua and colleagues wrote.

They went on to describe several therapeutic strategies worth further investigation.

“A key step to promote switching from the IT to IA phase is to lessen the richness of R. gnavus and bile acid bioconversion from cholesterol,” they wrote. The secretory products of A. muciniphila that successfully ameliorate the burden of R. gnavus outgrowth can be provided as useful means to induce anti-HBV efficacy. Also, the development of targeted probiotics or prebiotics that can modulate the gut microbiota composition to favor the beneficial effects of A. muciniphila while inhibiting the detrimental effects of R. gnavus may have translational value for CHB.”

The study was supported by the Ministry of Science and Technology, Executive Yuan, Taiwan and the Center of Precision Medicine from Featured Areas Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education in Taiwan. The investigators disclosed no conflicts of interest.

Two species of gut bacteria modulate the immune system and even the survival of one another to impact the progression of chronic hepatitis B (CHB), according to investigators.

While Ruminococcus gnavus promotes immune tolerance and therefore HBV persistence, Akkermansia muciniphila stimulates the immune system, promoting viral clearance, reported lead author Huey-Huey Chua, MD, of the National Taiwan University College of Medicine and Children’s Hospital, Taipei, and colleagues.

These findings could lead to new therapeutic strategies, such as administration of the secretory products of A. muciniphila, or provision of probiotics and prebiotics that tip the balance toward this more beneficial bacterium, the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology.

Their study, which included data from both human patients and mouse models of CHB, was grounded in prior research showing a link between gut microbiota and the age-dependence of HBV immunity.

“Sterilization of the gut microbiota using antibiotics prevents adult mice from rapidly clearing HBV and restores the tolerance phenotype, implying that the gut microbiota may transmit signals to break liver tolerance and evoke rapid HBV clearance,” Dr. Chua and colleagues wrote. “We hypothesized that the wax and wane of gut microbiota signatures may determine the progression of CHB. We aimed to delineate what the pivotal bacteria are and how they manipulate the progression of CHB.”

They began by analyzing fecal samples from 102 patients with CHB either in the immune-tolerant (IT) or immune-active (IA) phase of infection.

R. gnavus was the most abundant species among IT patients, whereas A. muciniphila was most abundant among patients in the IA phase. Higher levels of A. muciniphila were also associated with early hepatitis B e-antigen (HBeAG) loss, HBeAG seroconversion, and flares of aminotransferase. A mouse model echoed these findings.

Further experiments with mouse models revealed that R. gnavus modulates bile acids to promote HBV persistence and prolongation of the IT course. In opposition, A. muciniphila removes cholesterol and secretes metabolites that inhibit growth and function of R. gnavus.

“These novel findings will certainly confer a groundbreaking impact on the future therapy of CHB,” Dr. Chua and colleagues wrote.

They went on to describe several therapeutic strategies worth further investigation.

“A key step to promote switching from the IT to IA phase is to lessen the richness of R. gnavus and bile acid bioconversion from cholesterol,” they wrote. The secretory products of A. muciniphila that successfully ameliorate the burden of R. gnavus outgrowth can be provided as useful means to induce anti-HBV efficacy. Also, the development of targeted probiotics or prebiotics that can modulate the gut microbiota composition to favor the beneficial effects of A. muciniphila while inhibiting the detrimental effects of R. gnavus may have translational value for CHB.”

The study was supported by the Ministry of Science and Technology, Executive Yuan, Taiwan and the Center of Precision Medicine from Featured Areas Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education in Taiwan. The investigators disclosed no conflicts of interest.

The American Gastroenterological Association (AGA) has published a clinical practice update on polypectomy techniques.

The new guidance document, authored by Andrew P. Copland, MD, of the University of Virginia Health System, Charlottesville, and colleagues, includes 12 pieces of best practice advice pertaining to polyp removal, including the need for evaluation, considerations for selecting a resection strategy, and reasons for referral.

“Polypectomy techniques are continually evolving with improvements in the ability to assess polyps for high-risk features and with development of appropriate procedures for complete and safe polyp resection,” the authors wrote in Clinical Gastroenterology and Hepatology. “This clinical practice update provides guidance in characterizing polyps and choosing appropriate polypectomy techniques for polyps 2 cm or less in size, which comprise most polyps encountered by most endoscopists.”

UVA Health

To begin, they advised a “structured visual assessment using high-definition white light and/or electronic chromoendoscopy and with photodocumentation” for all polyps identified during routine colonoscopy, with close attention to any features suggesting submucosal invasion.

Next, in a series of statements, the guidance document steers appropriate use of various cold and hot polypectomy techniques.

Cold snare polypectomy should be used for polyps less than 10 mm in size, while cold forceps may be considered for polyps 1-3 mm in diameter. Cold resection techniques should also be used for serrated polyps, with use of submucosal injection, if needed, for polyps greater than 10 mm with unclear margins.

For polyps of intermediate size (10-19 mm), both cold and hot snare polypectomy should be considered, alongside endoscopic mucosal resection for polyps, Dr. Copland and colleagues wrote, noting that hot snare polypectomy should be used for removal of pedunculated lesions greater than 10 mm in size.

In contrast, the update advises against use of hot forceps polypectomy in any scenario.

“Hot forceps polypectomy for diminutive and small polyps is associated with higher incomplete polyp removal rates compared with cold snare polypectomy,” the update panelists wrote. “It is also associated with higher risks of postpolypectomy hemorrhage, particularly in the right colon with higher risks of deep thermal injury. Therefore, the use of hot forceps polypectomy is discouraged.”

In another best practice advice statement, the panelists advised against routine use of clips to close resection sites for polyps less than 20 mm. For larger polyps, they advised “selective use” of clips, most suitably in the proximal colon.

Alternatively, patients with polyps at least 20 mm in size should be considered for referral to endoscopic referral centers, along with patients who have polyps in “challenging” locations, and those with a recurrent polyp at a prior polypectomy site.

Patients with nonpedunculated polyps that exhibit “clear evidence of submucosally invasive cancer” should be referred for surgical evaluation, they added. On a similar note, the update advises tattooing lesions that may need to be located at a future surgery or endoscopy.

Finally, Dr. Copland and colleagues advised all endoscopists to understand appropriate selection of electrosurgical generator settings for various polypectomy or postpolypectomy thermal techniques.

“Ongoing research will allow further tailoring of polypectomy techniques to improve patient outcomes,” they concluded.This clinical practice update was commissioned and approved by the AGA Institute. The working group disclosed relationships with Olympus, Boston Scientific, GIE Medical, and others.

The American Gastroenterological Association (AGA) has published a clinical practice update on polypectomy techniques.

The new guidance document, authored by Andrew P. Copland, MD, of the University of Virginia Health System, Charlottesville, and colleagues, includes 12 pieces of best practice advice pertaining to polyp removal, including the need for evaluation, considerations for selecting a resection strategy, and reasons for referral.

“Polypectomy techniques are continually evolving with improvements in the ability to assess polyps for high-risk features and with development of appropriate procedures for complete and safe polyp resection,” the authors wrote in Clinical Gastroenterology and Hepatology. “This clinical practice update provides guidance in characterizing polyps and choosing appropriate polypectomy techniques for polyps 2 cm or less in size, which comprise most polyps encountered by most endoscopists.”

UVA Health

To begin, they advised a “structured visual assessment using high-definition white light and/or electronic chromoendoscopy and with photodocumentation” for all polyps identified during routine colonoscopy, with close attention to any features suggesting submucosal invasion.

Next, in a series of statements, the guidance document steers appropriate use of various cold and hot polypectomy techniques.

Cold snare polypectomy should be used for polyps less than 10 mm in size, while cold forceps may be considered for polyps 1-3 mm in diameter. Cold resection techniques should also be used for serrated polyps, with use of submucosal injection, if needed, for polyps greater than 10 mm with unclear margins.

For polyps of intermediate size (10-19 mm), both cold and hot snare polypectomy should be considered, alongside endoscopic mucosal resection for polyps, Dr. Copland and colleagues wrote, noting that hot snare polypectomy should be used for removal of pedunculated lesions greater than 10 mm in size.

In contrast, the update advises against use of hot forceps polypectomy in any scenario.

“Hot forceps polypectomy for diminutive and small polyps is associated with higher incomplete polyp removal rates compared with cold snare polypectomy,” the update panelists wrote. “It is also associated with higher risks of postpolypectomy hemorrhage, particularly in the right colon with higher risks of deep thermal injury. Therefore, the use of hot forceps polypectomy is discouraged.”

In another best practice advice statement, the panelists advised against routine use of clips to close resection sites for polyps less than 20 mm. For larger polyps, they advised “selective use” of clips, most suitably in the proximal colon.

Alternatively, patients with polyps at least 20 mm in size should be considered for referral to endoscopic referral centers, along with patients who have polyps in “challenging” locations, and those with a recurrent polyp at a prior polypectomy site.

Patients with nonpedunculated polyps that exhibit “clear evidence of submucosally invasive cancer” should be referred for surgical evaluation, they added. On a similar note, the update advises tattooing lesions that may need to be located at a future surgery or endoscopy.

Finally, Dr. Copland and colleagues advised all endoscopists to understand appropriate selection of electrosurgical generator settings for various polypectomy or postpolypectomy thermal techniques.

“Ongoing research will allow further tailoring of polypectomy techniques to improve patient outcomes,” they concluded.This clinical practice update was commissioned and approved by the AGA Institute. The working group disclosed relationships with Olympus, Boston Scientific, GIE Medical, and others.

The American Gastroenterological Association (AGA) has published a clinical practice update on polypectomy techniques.

The new guidance document, authored by Andrew P. Copland, MD, of the University of Virginia Health System, Charlottesville, and colleagues, includes 12 pieces of best practice advice pertaining to polyp removal, including the need for evaluation, considerations for selecting a resection strategy, and reasons for referral.

“Polypectomy techniques are continually evolving with improvements in the ability to assess polyps for high-risk features and with development of appropriate procedures for complete and safe polyp resection,” the authors wrote in Clinical Gastroenterology and Hepatology. “This clinical practice update provides guidance in characterizing polyps and choosing appropriate polypectomy techniques for polyps 2 cm or less in size, which comprise most polyps encountered by most endoscopists.”

UVA Health

To begin, they advised a “structured visual assessment using high-definition white light and/or electronic chromoendoscopy and with photodocumentation” for all polyps identified during routine colonoscopy, with close attention to any features suggesting submucosal invasion.

Next, in a series of statements, the guidance document steers appropriate use of various cold and hot polypectomy techniques.

Cold snare polypectomy should be used for polyps less than 10 mm in size, while cold forceps may be considered for polyps 1-3 mm in diameter. Cold resection techniques should also be used for serrated polyps, with use of submucosal injection, if needed, for polyps greater than 10 mm with unclear margins.

For polyps of intermediate size (10-19 mm), both cold and hot snare polypectomy should be considered, alongside endoscopic mucosal resection for polyps, Dr. Copland and colleagues wrote, noting that hot snare polypectomy should be used for removal of pedunculated lesions greater than 10 mm in size.

In contrast, the update advises against use of hot forceps polypectomy in any scenario.

“Hot forceps polypectomy for diminutive and small polyps is associated with higher incomplete polyp removal rates compared with cold snare polypectomy,” the update panelists wrote. “It is also associated with higher risks of postpolypectomy hemorrhage, particularly in the right colon with higher risks of deep thermal injury. Therefore, the use of hot forceps polypectomy is discouraged.”

In another best practice advice statement, the panelists advised against routine use of clips to close resection sites for polyps less than 20 mm. For larger polyps, they advised “selective use” of clips, most suitably in the proximal colon.

Alternatively, patients with polyps at least 20 mm in size should be considered for referral to endoscopic referral centers, along with patients who have polyps in “challenging” locations, and those with a recurrent polyp at a prior polypectomy site.

Patients with nonpedunculated polyps that exhibit “clear evidence of submucosally invasive cancer” should be referred for surgical evaluation, they added. On a similar note, the update advises tattooing lesions that may need to be located at a future surgery or endoscopy.

Finally, Dr. Copland and colleagues advised all endoscopists to understand appropriate selection of electrosurgical generator settings for various polypectomy or postpolypectomy thermal techniques.

“Ongoing research will allow further tailoring of polypectomy techniques to improve patient outcomes,” they concluded.This clinical practice update was commissioned and approved by the AGA Institute. The working group disclosed relationships with Olympus, Boston Scientific, GIE Medical, and others.

Colorectal cancer (CRC) epidemiology is changing due to a birth cohort effect, also called birth cohort CRC — the observed phenomena of the rising risk for CRC across successive generations of people born in 1960 and later — according to a new narrative review.

Birth cohort CRC is associated with increasing rectal cancer (greater than colon cancer) diagnosis and distant-stage (greater than local-stage) CRC diagnosis, and a rising incidence of early-onset CRC (EOCRC), defined as occurring before age 50.

Recognizing this birth cohort effect could improve the understanding of CRC risk factors, etiology, mechanisms, as well as the public health consequences of rising rates.

“The changing epidemiology means that we need to redouble our efforts at optimizing early detection and prevention of colorectal cancer,” Samir Gupta, MD, the review’s lead author and professor of gastroenterology at the University of California, San Diego, California, told this news organization. Dr. Gupta serves as the co-lead for the cancer control program at Moores Cancer Center at UC San Diego Health.

This requires “being alert for potential red flag signs and symptoms of colorectal cancer, such as iron deficiency anemia and rectal bleeding, that are otherwise unexplained, including for those under age 45,” he said.

We also should make “sure that all people eligible for screening — at age 45 and older — have every opportunity to get screened for colorectal cancer,” Dr. Gupta added.

The review was published online in Clinical Gastroenterology and Hepatology.
 

Tracking Birth Cohort Trends

CRC rates have increased in the United States among people born since the early 1960s, the authors wrote.

Generation X (individuals born in 1965-1980) experienced an increase in EOCRC, and rates subsequently increased in this generation after age 50. Rates are 1.22-fold higher among people born in 1965-1969 and 1.58-fold higher among those born 1975-1979 than among people born in 1950-1954.

Now rates are also increasing across younger generations, particularly among Millennials (individuals born in 1981-1996) as they enter mid-adulthood. Incidence rates are 1.89-fold higher among people born in 1980-1984 and 2.98-fold higher among those born in 1990-1994 than among individuals born in 1950-1954.

These birth cohort effects are evident globally, despite differences in population age structures, screening programs, and diagnostic strategies around the world. Due to this ongoing trend, physicians anticipate that CRC rates will likely continue to increase as higher-risk birth cohorts become older, the authors wrote.

Notably, four important shifts in CRC incidence are apparent, they noted. First, rates are steadily increasing up to age 50 and plateauing after age 60. Rectal cancers are now predominant through ages 50-59. Rates of distant-stage disease have increased most rapidly among ages 30-49 and more slowly decreased among ages 60-79 compared with those of local-stage disease. In addition, the increasing rates of EOCRC have been observed across all racial and ethnic groups since the early 1990s.

These shifts led to major changes in the types of patients diagnosed with CRC now vs 30 years ago, with a higher proportion being patients younger than 60, as well as Black, Asian or Pacific Islander, American Indian/Alaska Native, and Hispanic patients.

The combination of age-related increases in CRC and birth cohort–related trends will likely lead to substantial increases in the number of people diagnosed with CRC in coming years, especially as Generation X patients move into their 50s and 60s, the authors wrote.
 

Research and Clinical Implications

Birth cohort CRC, including increasing EOCRC incidence, likely is driven by a range of influences, including demographic, lifestyle, early life, environmental, genetic, and somatic factors, as well as interactions among them, the authors noted. Examples within these broad categories include male sex, food insecurity, income inequality, diabetes, alcohol use, less healthy dietary patterns, in utero exposure to certain medications, and microbiome concerns such as early life antibiotic exposure or dysbiosis.

“From a research perspective, this means that we need to think about risk factors and mechanisms that are associated with birth cohorts, not just age at diagnosis,” Dr. Gupta said. “To date, most studies of changing epidemiology have not taken into account birth cohort, such as whether someone is Generation X or later versus pre-Baby Boomer.”

Although additional research is needed, the epidemiology changes have several immediate clinical implications, Dr. Gupta said. For those younger than 45, it is critical to raise awareness about the signs and symptoms of CRC, such as hematochezia, iron deficiency anemia, and unintentional weight loss, as well as family history.

For ages 45 and older, a major focus should be placed on increasing screening participation and follow-up after abnormal results, addressing disparities in screening participation, and optimizing screening quality.

In addition, as CRC incidence continues to increase, health systems and policymakers should ensure every patient has access to guideline-appropriate care and innovative clinical trials, the authors wrote. This access may be particularly important to address the increasing burden of rectal cancer, as treatment approaches rapidly evolve toward more effective therapies, such as neoadjuvant chemotherapy and radiation prior to surgery, and with less-morbid treatments on the horizon, they added.
 

‘An Interesting Concept’

“Birth cohort CRC is an interesting concept that allows people to think of their CRC risk according to their birth cohort in addition to age,” Shuji Ogino, MD, PhD, chief of the Molecular Pathological Epidemiology program at Brigham & Women’s Hospital, Boston, Massachusetts, told this news organization.

Dr. Ogino, who wasn’t involved with this study, serves as a member of the cancer immunology and cancer epidemiology programs at the Dana-Farber Harvard Cancer Center. In studies of EOCRC, he and colleagues have found various biogeographical and pathogenic trends across age groups.

“More research is needed to disentangle the complex etiologies of birth cohort CRC and early-onset CRC,” Dr. Ogino said. “Tumor cells and tissues have certain past and ongoing pathological marks, which we can detect to better understand birth cohort CRC and early-onset CRC.”

The study was funded by several National Institutes of Health/National Cancer Institute grants. Dr. Gupta disclosed consulting for Geneoscopy, Guardant Health, Universal Diagnostics, InterVenn Bio, and CellMax. Another author reported consulting for Freenome, Exact Sciences, Medtronic, and Geneoscopy. Dr. Ogino reported no relevant financial disclosures. 

A version of this article appeared on Medscape.com .

Colorectal cancer (CRC) epidemiology is changing due to a birth cohort effect, also called birth cohort CRC — the observed phenomena of the rising risk for CRC across successive generations of people born in 1960 and later — according to a new narrative review.

Birth cohort CRC is associated with increasing rectal cancer (greater than colon cancer) diagnosis and distant-stage (greater than local-stage) CRC diagnosis, and a rising incidence of early-onset CRC (EOCRC), defined as occurring before age 50.

Recognizing this birth cohort effect could improve the understanding of CRC risk factors, etiology, mechanisms, as well as the public health consequences of rising rates.

“The changing epidemiology means that we need to redouble our efforts at optimizing early detection and prevention of colorectal cancer,” Samir Gupta, MD, the review’s lead author and professor of gastroenterology at the University of California, San Diego, California, told this news organization. Dr. Gupta serves as the co-lead for the cancer control program at Moores Cancer Center at UC San Diego Health.

This requires “being alert for potential red flag signs and symptoms of colorectal cancer, such as iron deficiency anemia and rectal bleeding, that are otherwise unexplained, including for those under age 45,” he said.

We also should make “sure that all people eligible for screening — at age 45 and older — have every opportunity to get screened for colorectal cancer,” Dr. Gupta added.

The review was published online in Clinical Gastroenterology and Hepatology.
 

Tracking Birth Cohort Trends

CRC rates have increased in the United States among people born since the early 1960s, the authors wrote.

Generation X (individuals born in 1965-1980) experienced an increase in EOCRC, and rates subsequently increased in this generation after age 50. Rates are 1.22-fold higher among people born in 1965-1969 and 1.58-fold higher among those born 1975-1979 than among people born in 1950-1954.

Now rates are also increasing across younger generations, particularly among Millennials (individuals born in 1981-1996) as they enter mid-adulthood. Incidence rates are 1.89-fold higher among people born in 1980-1984 and 2.98-fold higher among those born in 1990-1994 than among individuals born in 1950-1954.

These birth cohort effects are evident globally, despite differences in population age structures, screening programs, and diagnostic strategies around the world. Due to this ongoing trend, physicians anticipate that CRC rates will likely continue to increase as higher-risk birth cohorts become older, the authors wrote.

Notably, four important shifts in CRC incidence are apparent, they noted. First, rates are steadily increasing up to age 50 and plateauing after age 60. Rectal cancers are now predominant through ages 50-59. Rates of distant-stage disease have increased most rapidly among ages 30-49 and more slowly decreased among ages 60-79 compared with those of local-stage disease. In addition, the increasing rates of EOCRC have been observed across all racial and ethnic groups since the early 1990s.

These shifts led to major changes in the types of patients diagnosed with CRC now vs 30 years ago, with a higher proportion being patients younger than 60, as well as Black, Asian or Pacific Islander, American Indian/Alaska Native, and Hispanic patients.

The combination of age-related increases in CRC and birth cohort–related trends will likely lead to substantial increases in the number of people diagnosed with CRC in coming years, especially as Generation X patients move into their 50s and 60s, the authors wrote.
 

Research and Clinical Implications

Birth cohort CRC, including increasing EOCRC incidence, likely is driven by a range of influences, including demographic, lifestyle, early life, environmental, genetic, and somatic factors, as well as interactions among them, the authors noted. Examples within these broad categories include male sex, food insecurity, income inequality, diabetes, alcohol use, less healthy dietary patterns, in utero exposure to certain medications, and microbiome concerns such as early life antibiotic exposure or dysbiosis.

“From a research perspective, this means that we need to think about risk factors and mechanisms that are associated with birth cohorts, not just age at diagnosis,” Dr. Gupta said. “To date, most studies of changing epidemiology have not taken into account birth cohort, such as whether someone is Generation X or later versus pre-Baby Boomer.”

Although additional research is needed, the epidemiology changes have several immediate clinical implications, Dr. Gupta said. For those younger than 45, it is critical to raise awareness about the signs and symptoms of CRC, such as hematochezia, iron deficiency anemia, and unintentional weight loss, as well as family history.

For ages 45 and older, a major focus should be placed on increasing screening participation and follow-up after abnormal results, addressing disparities in screening participation, and optimizing screening quality.

In addition, as CRC incidence continues to increase, health systems and policymakers should ensure every patient has access to guideline-appropriate care and innovative clinical trials, the authors wrote. This access may be particularly important to address the increasing burden of rectal cancer, as treatment approaches rapidly evolve toward more effective therapies, such as neoadjuvant chemotherapy and radiation prior to surgery, and with less-morbid treatments on the horizon, they added.
 

‘An Interesting Concept’

“Birth cohort CRC is an interesting concept that allows people to think of their CRC risk according to their birth cohort in addition to age,” Shuji Ogino, MD, PhD, chief of the Molecular Pathological Epidemiology program at Brigham & Women’s Hospital, Boston, Massachusetts, told this news organization.

Dr. Ogino, who wasn’t involved with this study, serves as a member of the cancer immunology and cancer epidemiology programs at the Dana-Farber Harvard Cancer Center. In studies of EOCRC, he and colleagues have found various biogeographical and pathogenic trends across age groups.

“More research is needed to disentangle the complex etiologies of birth cohort CRC and early-onset CRC,” Dr. Ogino said. “Tumor cells and tissues have certain past and ongoing pathological marks, which we can detect to better understand birth cohort CRC and early-onset CRC.”

The study was funded by several National Institutes of Health/National Cancer Institute grants. Dr. Gupta disclosed consulting for Geneoscopy, Guardant Health, Universal Diagnostics, InterVenn Bio, and CellMax. Another author reported consulting for Freenome, Exact Sciences, Medtronic, and Geneoscopy. Dr. Ogino reported no relevant financial disclosures. 

A version of this article appeared on Medscape.com .

Colorectal cancer (CRC) epidemiology is changing due to a birth cohort effect, also called birth cohort CRC — the observed phenomena of the rising risk for CRC across successive generations of people born in 1960 and later — according to a new narrative review.

Birth cohort CRC is associated with increasing rectal cancer (greater than colon cancer) diagnosis and distant-stage (greater than local-stage) CRC diagnosis, and a rising incidence of early-onset CRC (EOCRC), defined as occurring before age 50.

Recognizing this birth cohort effect could improve the understanding of CRC risk factors, etiology, mechanisms, as well as the public health consequences of rising rates.

“The changing epidemiology means that we need to redouble our efforts at optimizing early detection and prevention of colorectal cancer,” Samir Gupta, MD, the review’s lead author and professor of gastroenterology at the University of California, San Diego, California, told this news organization. Dr. Gupta serves as the co-lead for the cancer control program at Moores Cancer Center at UC San Diego Health.

This requires “being alert for potential red flag signs and symptoms of colorectal cancer, such as iron deficiency anemia and rectal bleeding, that are otherwise unexplained, including for those under age 45,” he said.

We also should make “sure that all people eligible for screening — at age 45 and older — have every opportunity to get screened for colorectal cancer,” Dr. Gupta added.

The review was published online in Clinical Gastroenterology and Hepatology.
 

Tracking Birth Cohort Trends

CRC rates have increased in the United States among people born since the early 1960s, the authors wrote.

Generation X (individuals born in 1965-1980) experienced an increase in EOCRC, and rates subsequently increased in this generation after age 50. Rates are 1.22-fold higher among people born in 1965-1969 and 1.58-fold higher among those born 1975-1979 than among people born in 1950-1954.

Now rates are also increasing across younger generations, particularly among Millennials (individuals born in 1981-1996) as they enter mid-adulthood. Incidence rates are 1.89-fold higher among people born in 1980-1984 and 2.98-fold higher among those born in 1990-1994 than among individuals born in 1950-1954.

These birth cohort effects are evident globally, despite differences in population age structures, screening programs, and diagnostic strategies around the world. Due to this ongoing trend, physicians anticipate that CRC rates will likely continue to increase as higher-risk birth cohorts become older, the authors wrote.

Notably, four important shifts in CRC incidence are apparent, they noted. First, rates are steadily increasing up to age 50 and plateauing after age 60. Rectal cancers are now predominant through ages 50-59. Rates of distant-stage disease have increased most rapidly among ages 30-49 and more slowly decreased among ages 60-79 compared with those of local-stage disease. In addition, the increasing rates of EOCRC have been observed across all racial and ethnic groups since the early 1990s.

These shifts led to major changes in the types of patients diagnosed with CRC now vs 30 years ago, with a higher proportion being patients younger than 60, as well as Black, Asian or Pacific Islander, American Indian/Alaska Native, and Hispanic patients.

The combination of age-related increases in CRC and birth cohort–related trends will likely lead to substantial increases in the number of people diagnosed with CRC in coming years, especially as Generation X patients move into their 50s and 60s, the authors wrote.
 

Research and Clinical Implications

Birth cohort CRC, including increasing EOCRC incidence, likely is driven by a range of influences, including demographic, lifestyle, early life, environmental, genetic, and somatic factors, as well as interactions among them, the authors noted. Examples within these broad categories include male sex, food insecurity, income inequality, diabetes, alcohol use, less healthy dietary patterns, in utero exposure to certain medications, and microbiome concerns such as early life antibiotic exposure or dysbiosis.

“From a research perspective, this means that we need to think about risk factors and mechanisms that are associated with birth cohorts, not just age at diagnosis,” Dr. Gupta said. “To date, most studies of changing epidemiology have not taken into account birth cohort, such as whether someone is Generation X or later versus pre-Baby Boomer.”

Although additional research is needed, the epidemiology changes have several immediate clinical implications, Dr. Gupta said. For those younger than 45, it is critical to raise awareness about the signs and symptoms of CRC, such as hematochezia, iron deficiency anemia, and unintentional weight loss, as well as family history.

For ages 45 and older, a major focus should be placed on increasing screening participation and follow-up after abnormal results, addressing disparities in screening participation, and optimizing screening quality.

In addition, as CRC incidence continues to increase, health systems and policymakers should ensure every patient has access to guideline-appropriate care and innovative clinical trials, the authors wrote. This access may be particularly important to address the increasing burden of rectal cancer, as treatment approaches rapidly evolve toward more effective therapies, such as neoadjuvant chemotherapy and radiation prior to surgery, and with less-morbid treatments on the horizon, they added.
 

‘An Interesting Concept’

“Birth cohort CRC is an interesting concept that allows people to think of their CRC risk according to their birth cohort in addition to age,” Shuji Ogino, MD, PhD, chief of the Molecular Pathological Epidemiology program at Brigham & Women’s Hospital, Boston, Massachusetts, told this news organization.

Dr. Ogino, who wasn’t involved with this study, serves as a member of the cancer immunology and cancer epidemiology programs at the Dana-Farber Harvard Cancer Center. In studies of EOCRC, he and colleagues have found various biogeographical and pathogenic trends across age groups.

“More research is needed to disentangle the complex etiologies of birth cohort CRC and early-onset CRC,” Dr. Ogino said. “Tumor cells and tissues have certain past and ongoing pathological marks, which we can detect to better understand birth cohort CRC and early-onset CRC.”

The study was funded by several National Institutes of Health/National Cancer Institute grants. Dr. Gupta disclosed consulting for Geneoscopy, Guardant Health, Universal Diagnostics, InterVenn Bio, and CellMax. Another author reported consulting for Freenome, Exact Sciences, Medtronic, and Geneoscopy. Dr. Ogino reported no relevant financial disclosures. 

A version of this article appeared on Medscape.com .

Certain patients with irritable bowel syndrome (IBS) may benefit from treatment with mesalamine, although the quality of evidence supporting this strategy remains low, according to a recent systematic literature review and meta-analysis.

Global IBS symptoms improved significantly across the entire population, however, a subgroup analysis suggested that mesalamine may be most beneficial for patients who present with diarrhea, providing support for a large clinical trial in this patient population, reported lead author Vivek C. Goodoory, MBChB, of St. James’s University Hospital, Leeds, United Kingdom, and colleagues.

Some patients with IBS may present with low-grade inflammation in the intestine, offering theoretical grounds for prescribing mesalamine, which is typically used for treating ulcerative colitis, the investigators wrote in Clinical Gastroenterology and Hepatology. Yet previous randomized controlled trials (RCTs) evaluating mesalamine for IBS have yielded mixed results, and a meta-analysis showed that mesalamine offered no benefit.

According to Dr. Goodoory and colleagues, however, that meta-analysis fell short since it “only pooled mean symptom scores, rather than the proportion of patients in each trial experiencing an improvement in symptoms, and did not appear to include data from all available RCTs.” Furthermore, they noted that this prior study lacked subgroup analyses conducted based on IBS subtype or postinfection status.

“We, therefore, conducted a contemporaneous meta-analysis to examine the efficacy and safety of mesalamine in IBS addressing these deficits in knowledge,” the investigators wrote.

Their meta-analysis included 820 patients from 8 RCTs published between 2009 and 2022. Efficacy and safety were evaluated via dichotomous assessments of global IBS symptoms, bowel habit or stool frequency, abdominal pain, and adverse events. Two subgroup analyses were planned to evaluate responses based on post-infection status and predominant stool pattern.

Unlike the previous meta-analysis, Dr. Goodoory and colleagues detected a potential signal for efficacy.

Across all patients, mesalamine was associated with significant improvement in global IBS symptoms, compared with placebo (relative risk [RR], 0.86; 95% CI, 0.79-0.95). However, no significant improvements were detected for abdominal pain or bowel habit/stool frequency.

A subgroup analysis of patients exhibiting IBS with diarrhea showed significantly greater improvements in global IBS symptoms for mesalamine versus placebo (RR, 0.88; 95% CI, 0.79-0.99). This subgroup showed no improvements in abdominal pain or bowel habit/stool frequency.

Subgroup analyses for patients with constipation or mixed bowel habits, or based on postinfection status, revealed no significant differences, although the investigators noted that relevant data were limited.

Mesalamine appeared to be well tolerated. Across five studies reporting adverse events, 43.5% of patients receiving mesalamine reported any adverse event, compared with 41.4% of patients on placebo. The RR of experiencing an adverse event in those taking mesalamine was 1.20 (95% CI, 0.89-1.63), which was not statistically significant.

“There was no evidence of heterogeneity between studies in most of our analyses, but only one trial was at low risk of bias across all domains, and there were insufficient studies to assess for funnel plot asymmetry,” Dr. Goodoory and colleagues wrote. “Based on these limitations of the evidence,” they continued, “our confidence in the results of the meta-analysis would be low, and further large trials at low risk of bias would be informative.”

Specifically, the investigators suggested an RCT recruiting only patients with IBS with diarrhea, and reporting efficacy according to postinfection status.

One coauthor reported research funding from Tillotts Pharma and Dr Falk Pharma UK. The remaining authors reported no conflicts.

Certain patients with irritable bowel syndrome (IBS) may benefit from treatment with mesalamine, although the quality of evidence supporting this strategy remains low, according to a recent systematic literature review and meta-analysis.

Global IBS symptoms improved significantly across the entire population, however, a subgroup analysis suggested that mesalamine may be most beneficial for patients who present with diarrhea, providing support for a large clinical trial in this patient population, reported lead author Vivek C. Goodoory, MBChB, of St. James’s University Hospital, Leeds, United Kingdom, and colleagues.

Some patients with IBS may present with low-grade inflammation in the intestine, offering theoretical grounds for prescribing mesalamine, which is typically used for treating ulcerative colitis, the investigators wrote in Clinical Gastroenterology and Hepatology. Yet previous randomized controlled trials (RCTs) evaluating mesalamine for IBS have yielded mixed results, and a meta-analysis showed that mesalamine offered no benefit.

According to Dr. Goodoory and colleagues, however, that meta-analysis fell short since it “only pooled mean symptom scores, rather than the proportion of patients in each trial experiencing an improvement in symptoms, and did not appear to include data from all available RCTs.” Furthermore, they noted that this prior study lacked subgroup analyses conducted based on IBS subtype or postinfection status.

“We, therefore, conducted a contemporaneous meta-analysis to examine the efficacy and safety of mesalamine in IBS addressing these deficits in knowledge,” the investigators wrote.

Their meta-analysis included 820 patients from 8 RCTs published between 2009 and 2022. Efficacy and safety were evaluated via dichotomous assessments of global IBS symptoms, bowel habit or stool frequency, abdominal pain, and adverse events. Two subgroup analyses were planned to evaluate responses based on post-infection status and predominant stool pattern.

Unlike the previous meta-analysis, Dr. Goodoory and colleagues detected a potential signal for efficacy.

Across all patients, mesalamine was associated with significant improvement in global IBS symptoms, compared with placebo (relative risk [RR], 0.86; 95% CI, 0.79-0.95). However, no significant improvements were detected for abdominal pain or bowel habit/stool frequency.

A subgroup analysis of patients exhibiting IBS with diarrhea showed significantly greater improvements in global IBS symptoms for mesalamine versus placebo (RR, 0.88; 95% CI, 0.79-0.99). This subgroup showed no improvements in abdominal pain or bowel habit/stool frequency.

Subgroup analyses for patients with constipation or mixed bowel habits, or based on postinfection status, revealed no significant differences, although the investigators noted that relevant data were limited.

Mesalamine appeared to be well tolerated. Across five studies reporting adverse events, 43.5% of patients receiving mesalamine reported any adverse event, compared with 41.4% of patients on placebo. The RR of experiencing an adverse event in those taking mesalamine was 1.20 (95% CI, 0.89-1.63), which was not statistically significant.

“There was no evidence of heterogeneity between studies in most of our analyses, but only one trial was at low risk of bias across all domains, and there were insufficient studies to assess for funnel plot asymmetry,” Dr. Goodoory and colleagues wrote. “Based on these limitations of the evidence,” they continued, “our confidence in the results of the meta-analysis would be low, and further large trials at low risk of bias would be informative.”

Specifically, the investigators suggested an RCT recruiting only patients with IBS with diarrhea, and reporting efficacy according to postinfection status.

One coauthor reported research funding from Tillotts Pharma and Dr Falk Pharma UK. The remaining authors reported no conflicts.

Certain patients with irritable bowel syndrome (IBS) may benefit from treatment with mesalamine, although the quality of evidence supporting this strategy remains low, according to a recent systematic literature review and meta-analysis.

Global IBS symptoms improved significantly across the entire population, however, a subgroup analysis suggested that mesalamine may be most beneficial for patients who present with diarrhea, providing support for a large clinical trial in this patient population, reported lead author Vivek C. Goodoory, MBChB, of St. James’s University Hospital, Leeds, United Kingdom, and colleagues.

Some patients with IBS may present with low-grade inflammation in the intestine, offering theoretical grounds for prescribing mesalamine, which is typically used for treating ulcerative colitis, the investigators wrote in Clinical Gastroenterology and Hepatology. Yet previous randomized controlled trials (RCTs) evaluating mesalamine for IBS have yielded mixed results, and a meta-analysis showed that mesalamine offered no benefit.

According to Dr. Goodoory and colleagues, however, that meta-analysis fell short since it “only pooled mean symptom scores, rather than the proportion of patients in each trial experiencing an improvement in symptoms, and did not appear to include data from all available RCTs.” Furthermore, they noted that this prior study lacked subgroup analyses conducted based on IBS subtype or postinfection status.

“We, therefore, conducted a contemporaneous meta-analysis to examine the efficacy and safety of mesalamine in IBS addressing these deficits in knowledge,” the investigators wrote.

Their meta-analysis included 820 patients from 8 RCTs published between 2009 and 2022. Efficacy and safety were evaluated via dichotomous assessments of global IBS symptoms, bowel habit or stool frequency, abdominal pain, and adverse events. Two subgroup analyses were planned to evaluate responses based on post-infection status and predominant stool pattern.

Unlike the previous meta-analysis, Dr. Goodoory and colleagues detected a potential signal for efficacy.

Across all patients, mesalamine was associated with significant improvement in global IBS symptoms, compared with placebo (relative risk [RR], 0.86; 95% CI, 0.79-0.95). However, no significant improvements were detected for abdominal pain or bowel habit/stool frequency.

A subgroup analysis of patients exhibiting IBS with diarrhea showed significantly greater improvements in global IBS symptoms for mesalamine versus placebo (RR, 0.88; 95% CI, 0.79-0.99). This subgroup showed no improvements in abdominal pain or bowel habit/stool frequency.

Subgroup analyses for patients with constipation or mixed bowel habits, or based on postinfection status, revealed no significant differences, although the investigators noted that relevant data were limited.

Mesalamine appeared to be well tolerated. Across five studies reporting adverse events, 43.5% of patients receiving mesalamine reported any adverse event, compared with 41.4% of patients on placebo. The RR of experiencing an adverse event in those taking mesalamine was 1.20 (95% CI, 0.89-1.63), which was not statistically significant.

“There was no evidence of heterogeneity between studies in most of our analyses, but only one trial was at low risk of bias across all domains, and there were insufficient studies to assess for funnel plot asymmetry,” Dr. Goodoory and colleagues wrote. “Based on these limitations of the evidence,” they continued, “our confidence in the results of the meta-analysis would be low, and further large trials at low risk of bias would be informative.”

Specifically, the investigators suggested an RCT recruiting only patients with IBS with diarrhea, and reporting efficacy according to postinfection status.

One coauthor reported research funding from Tillotts Pharma and Dr Falk Pharma UK. The remaining authors reported no conflicts.

The American Gastroenterological Association (AGA) has published a new clinical practice guideline on the management of pouchitis and inflammatory pouch disorders.

The guidance document, authored by Edward L. Barnes, MD, of the University of North Carolina at Chapel Hill and colleagues, includes eleven conditional recommendations that steer usage of probiotics, antibiotics, and immunosuppressive therapies in patients with these conditions, which occur most often after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC).

Jennifer Layton, MBA

“Multiple strategies have been utilized in the treatment and prevention of pouchitis and inflammatory pouch conditions, including antibiotics, probiotics, corticosteroids, and advanced immunosuppressive therapies including biologics and oral small-molecule drugs,” the guideline panelists wrote on the AGA website. “However, most of the evidence base is primarily derived from retrospective observational studies or comparisons of small cohorts. Data on patients’ values and preferences for specific management decisions and treatment choices are also limited. This results in substantial practice variability.”

Still, the area is advancing. Dr. Barnes and colleagues highlighted new scoring systems for characterizing endoscopic findings and patient-reported outcomes, as well as the recent EARNEST trial (N Engl J Med. 2023 Mar 30;388(13):1191-1200), which compared vedolizumab with placebo in patients with chronic refractory pouchitis, and should be considered a “landmark study in the field,” as it could shape future trial design.

Based on all available evidence and clinical experience, the panelists issued the following recommendations, which were approved by the AGA Governing Board.
 

Probiotics

Because of a knowledge gap, the guideline makes no recommendation for or against use of probiotics for either the primary prevention or treatment of pouchitis.

They offered a similar explanation for the lack of guidance on using probiotics to treat pouchitis, and noted that antibiotics have demonstrated effectiveness where probiotics have not, making them the preferred treatment choice.

“There is potential that delaying therapy or using probiotics when they are not as effective as antibiotics may have significant impact on an individual patient’s quality of life,” Dr. Barnes and colleagues noted.

In contrast with the above statements, the guideline recommends usage of probiotics to prevent recurrent pouchitis in patients with recurrent, antibiotic-responsive pouchitis.

The De Simone formulation of multistrain probiotics is best supported in this scenario, the guideline notes, as this product was used in clinical trials, which collectively showed an 87% reduced risk of relapse over 12 months.
 

Antibiotics

Although the guideline supports antibiotics for prevention of pouchitis, the panelists noted that only one randomized controlled trial supports this recommendation, and negative effects of long-term usage need to be considered, including promotion of drug-resistant organisms and risk of Clostridioides difficile infection.

Dr. Barnes and colleagues cited more data supporting antibiotics for treatment of pouchitis, and noted that metronidazole and/or ciprofloxacin remain the preferred choices, with a typical duration of 2-4 weeks.

“An approach using a combination of antibiotics may be more effective in patients who do not respond to single-antibiotic therapy,” the panelists wrote, noting that oral vancomycin may also be considered when a patient does not respond to initial therapy.

For patients with recurrent pouchitis that relapses shortly after discontinuing antibiotics, chronic antibiotics should be considered, according to the guideline.

Immunosuppressive therapies

Advanced immunosuppressive therapies are recommended for patients with chronic antibiotic-dependent pouchitis, including those approved for treatment of UC or Crohn’s disease.

“Advanced immunosuppressive therapies may be used in lieu of chronic, continuous antibiotic therapy, particularly in patients who are intolerant to antibiotics or where patients and/or providers are concerned about risks of long-term antibiotic therapy,” the panelists wrote.

For patients with chronic antibiotic-refractory pouchitis, the guideline makes a general recommendation for advanced immunosuppressive therapies while specifically noting that vedolizumab has a greater strength of evidence in this scenario, citing the EARNEST trial.

A separate recommendation for corticosteroids is made for the same patient group, with ileal-release budesonide remaining the preferred formulation. In contrast, mesalamine is not recommended, based on a lack of supporting evidence.

Finally, the panelists recommend using corticosteroids in patients with Crohn’s-like disease of the pouch.
 

Future directions

“Even though pouchitis is relatively common after IPAA for UC, we observed that most of the evidence informing these guidelines was low to very low quality, derived from case series or small cohort studies, and several knowledge gaps exist,” Dr. Barnes and colleagues wrote. “Several initiatives towards improving management of inflammatory pouch disorders are already underway. However, concerted efforts in key domains are central towards improving patient care.”

They suggested that research should focus on standardizing disease entities, characterizing natural history and risk factors for inflammatory disorders of the pouch, and improving clinical trial design.The guideline was funded by the AGA Institute. The panelists disclosed relationships with Bristol-Myers Squibb, Sandoz, AbbVie, and others.

The American Gastroenterological Association (AGA) has published a new clinical practice guideline on the management of pouchitis and inflammatory pouch disorders.

The guidance document, authored by Edward L. Barnes, MD, of the University of North Carolina at Chapel Hill and colleagues, includes eleven conditional recommendations that steer usage of probiotics, antibiotics, and immunosuppressive therapies in patients with these conditions, which occur most often after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC).

Jennifer Layton, MBA

“Multiple strategies have been utilized in the treatment and prevention of pouchitis and inflammatory pouch conditions, including antibiotics, probiotics, corticosteroids, and advanced immunosuppressive therapies including biologics and oral small-molecule drugs,” the guideline panelists wrote on the AGA website. “However, most of the evidence base is primarily derived from retrospective observational studies or comparisons of small cohorts. Data on patients’ values and preferences for specific management decisions and treatment choices are also limited. This results in substantial practice variability.”

Still, the area is advancing. Dr. Barnes and colleagues highlighted new scoring systems for characterizing endoscopic findings and patient-reported outcomes, as well as the recent EARNEST trial (N Engl J Med. 2023 Mar 30;388(13):1191-1200), which compared vedolizumab with placebo in patients with chronic refractory pouchitis, and should be considered a “landmark study in the field,” as it could shape future trial design.

Based on all available evidence and clinical experience, the panelists issued the following recommendations, which were approved by the AGA Governing Board.
 

Probiotics

Because of a knowledge gap, the guideline makes no recommendation for or against use of probiotics for either the primary prevention or treatment of pouchitis.

They offered a similar explanation for the lack of guidance on using probiotics to treat pouchitis, and noted that antibiotics have demonstrated effectiveness where probiotics have not, making them the preferred treatment choice.

“There is potential that delaying therapy or using probiotics when they are not as effective as antibiotics may have significant impact on an individual patient’s quality of life,” Dr. Barnes and colleagues noted.

In contrast with the above statements, the guideline recommends usage of probiotics to prevent recurrent pouchitis in patients with recurrent, antibiotic-responsive pouchitis.

The De Simone formulation of multistrain probiotics is best supported in this scenario, the guideline notes, as this product was used in clinical trials, which collectively showed an 87% reduced risk of relapse over 12 months.
 

Antibiotics

Although the guideline supports antibiotics for prevention of pouchitis, the panelists noted that only one randomized controlled trial supports this recommendation, and negative effects of long-term usage need to be considered, including promotion of drug-resistant organisms and risk of Clostridioides difficile infection.

Dr. Barnes and colleagues cited more data supporting antibiotics for treatment of pouchitis, and noted that metronidazole and/or ciprofloxacin remain the preferred choices, with a typical duration of 2-4 weeks.

“An approach using a combination of antibiotics may be more effective in patients who do not respond to single-antibiotic therapy,” the panelists wrote, noting that oral vancomycin may also be considered when a patient does not respond to initial therapy.

For patients with recurrent pouchitis that relapses shortly after discontinuing antibiotics, chronic antibiotics should be considered, according to the guideline.

Immunosuppressive therapies

Advanced immunosuppressive therapies are recommended for patients with chronic antibiotic-dependent pouchitis, including those approved for treatment of UC or Crohn’s disease.

“Advanced immunosuppressive therapies may be used in lieu of chronic, continuous antibiotic therapy, particularly in patients who are intolerant to antibiotics or where patients and/or providers are concerned about risks of long-term antibiotic therapy,” the panelists wrote.

For patients with chronic antibiotic-refractory pouchitis, the guideline makes a general recommendation for advanced immunosuppressive therapies while specifically noting that vedolizumab has a greater strength of evidence in this scenario, citing the EARNEST trial.

A separate recommendation for corticosteroids is made for the same patient group, with ileal-release budesonide remaining the preferred formulation. In contrast, mesalamine is not recommended, based on a lack of supporting evidence.

Finally, the panelists recommend using corticosteroids in patients with Crohn’s-like disease of the pouch.
 

Future directions

“Even though pouchitis is relatively common after IPAA for UC, we observed that most of the evidence informing these guidelines was low to very low quality, derived from case series or small cohort studies, and several knowledge gaps exist,” Dr. Barnes and colleagues wrote. “Several initiatives towards improving management of inflammatory pouch disorders are already underway. However, concerted efforts in key domains are central towards improving patient care.”

They suggested that research should focus on standardizing disease entities, characterizing natural history and risk factors for inflammatory disorders of the pouch, and improving clinical trial design.The guideline was funded by the AGA Institute. The panelists disclosed relationships with Bristol-Myers Squibb, Sandoz, AbbVie, and others.

The American Gastroenterological Association (AGA) has published a new clinical practice guideline on the management of pouchitis and inflammatory pouch disorders.

The guidance document, authored by Edward L. Barnes, MD, of the University of North Carolina at Chapel Hill and colleagues, includes eleven conditional recommendations that steer usage of probiotics, antibiotics, and immunosuppressive therapies in patients with these conditions, which occur most often after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC).

Jennifer Layton, MBA

“Multiple strategies have been utilized in the treatment and prevention of pouchitis and inflammatory pouch conditions, including antibiotics, probiotics, corticosteroids, and advanced immunosuppressive therapies including biologics and oral small-molecule drugs,” the guideline panelists wrote on the AGA website. “However, most of the evidence base is primarily derived from retrospective observational studies or comparisons of small cohorts. Data on patients’ values and preferences for specific management decisions and treatment choices are also limited. This results in substantial practice variability.”

Still, the area is advancing. Dr. Barnes and colleagues highlighted new scoring systems for characterizing endoscopic findings and patient-reported outcomes, as well as the recent EARNEST trial (N Engl J Med. 2023 Mar 30;388(13):1191-1200), which compared vedolizumab with placebo in patients with chronic refractory pouchitis, and should be considered a “landmark study in the field,” as it could shape future trial design.

Based on all available evidence and clinical experience, the panelists issued the following recommendations, which were approved by the AGA Governing Board.
 

Probiotics

Because of a knowledge gap, the guideline makes no recommendation for or against use of probiotics for either the primary prevention or treatment of pouchitis.

They offered a similar explanation for the lack of guidance on using probiotics to treat pouchitis, and noted that antibiotics have demonstrated effectiveness where probiotics have not, making them the preferred treatment choice.

“There is potential that delaying therapy or using probiotics when they are not as effective as antibiotics may have significant impact on an individual patient’s quality of life,” Dr. Barnes and colleagues noted.

In contrast with the above statements, the guideline recommends usage of probiotics to prevent recurrent pouchitis in patients with recurrent, antibiotic-responsive pouchitis.

The De Simone formulation of multistrain probiotics is best supported in this scenario, the guideline notes, as this product was used in clinical trials, which collectively showed an 87% reduced risk of relapse over 12 months.
 

Antibiotics

Although the guideline supports antibiotics for prevention of pouchitis, the panelists noted that only one randomized controlled trial supports this recommendation, and negative effects of long-term usage need to be considered, including promotion of drug-resistant organisms and risk of Clostridioides difficile infection.

Dr. Barnes and colleagues cited more data supporting antibiotics for treatment of pouchitis, and noted that metronidazole and/or ciprofloxacin remain the preferred choices, with a typical duration of 2-4 weeks.

“An approach using a combination of antibiotics may be more effective in patients who do not respond to single-antibiotic therapy,” the panelists wrote, noting that oral vancomycin may also be considered when a patient does not respond to initial therapy.

For patients with recurrent pouchitis that relapses shortly after discontinuing antibiotics, chronic antibiotics should be considered, according to the guideline.

Immunosuppressive therapies

Advanced immunosuppressive therapies are recommended for patients with chronic antibiotic-dependent pouchitis, including those approved for treatment of UC or Crohn’s disease.

“Advanced immunosuppressive therapies may be used in lieu of chronic, continuous antibiotic therapy, particularly in patients who are intolerant to antibiotics or where patients and/or providers are concerned about risks of long-term antibiotic therapy,” the panelists wrote.

For patients with chronic antibiotic-refractory pouchitis, the guideline makes a general recommendation for advanced immunosuppressive therapies while specifically noting that vedolizumab has a greater strength of evidence in this scenario, citing the EARNEST trial.

A separate recommendation for corticosteroids is made for the same patient group, with ileal-release budesonide remaining the preferred formulation. In contrast, mesalamine is not recommended, based on a lack of supporting evidence.

Finally, the panelists recommend using corticosteroids in patients with Crohn’s-like disease of the pouch.
 

Future directions

“Even though pouchitis is relatively common after IPAA for UC, we observed that most of the evidence informing these guidelines was low to very low quality, derived from case series or small cohort studies, and several knowledge gaps exist,” Dr. Barnes and colleagues wrote. “Several initiatives towards improving management of inflammatory pouch disorders are already underway. However, concerted efforts in key domains are central towards improving patient care.”

They suggested that research should focus on standardizing disease entities, characterizing natural history and risk factors for inflammatory disorders of the pouch, and improving clinical trial design.The guideline was funded by the AGA Institute. The panelists disclosed relationships with Bristol-Myers Squibb, Sandoz, AbbVie, and others.