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Intensive Nutrition Therapy Improves Outcomes in Alcohol-Related ACLF
In a randomized controlled trial, compared with standard care, dietitian-supported, intensive nutritional therapy improved survival, reduced frailty, and lowered hospitalization rates in men with alcohol-related ACLF.
The study, performed by a team from the Postgraduate Institute of Medical Education and Research, Chandigarh, India, was published in Clinical Gastroenterology and Hepatology.
ACLF related to alcohol use is associated with poor outcomes due to poor nutritional intake and frailty. Frail patients with ACLF face higher morbidity, mortality, and hospitalization rates than their nonfrail counterparts. However, research on the role of structured nutritional interventions in improving these outcomes is limited.
Patal Giri, MBBS, MD, and colleagues enrolled 70 men with alcohol-related ACLF and frailty (liver frailty index [LFI] > 4.5) in a single-center, open-label study. Half were randomly allocated to an intervention group receiving outpatient intensive nutrition therapy (OINT) plus standard medical treatment (SMT) and half to a control group receiving SMT alone for 3 months.
The intervention group received a monitored high-calorie, high-protein, and salt-restricted diet as prescribed by a dedicated senior liver dietitian. The control group received regular nutritional recommendations and were managed for the ACLF-associated complications, without intervention or guidance by the study team.
After 3 months follow-up, overall survival (the primary outcome) was significantly improved in the OINT group compared with the control group (91.4% vs 57.1%), “suggesting that the improvement in nutrition status is associated with better survival,” the study team noted. Three patients died in the OINT group vs 15 in the SMT group.
OINT also led to a significant improvement in frailty, with LFI scores decreasing by an average of 0.93 in the intervention group vs 0.33 in the control group; 97% of patients improved from frail to prefrail status in the OINT group, whereas only 20% of patients improved in the SMT group.
The mean change in LFI of 0.93 with OINT is “well above the substantially clinically important difference” (change of 0.8) established in a previous study, the authors noted.
Significant improvements in weight and body mass index were also observed in the OINT group relative to the control group.
Liver disease severity, including model for end-stage liver disease (MELD) scores, showed greater improvement in the OINT group than in the control group (−8.7 vs −6.3 points from baseline to 3 months).
During the follow-up period, fewer patients in the intervention group than in the control group required a hospital stay (17% vs 45.7%).
Limitations of the study include the single-center design and the short follow-up period of 3 months, which limits long-term outcome assessment. Further, the study only included patients meeting Asia Pacific Association for Study of Liver criteria for ACLF, which does not include the patients with organ failure as defined by European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria. Patients with ACLF who had more severe disease (MELD score > 30 or AARC > 10) were also not included.
Despite these limitations, the authors said their study showed that “dietician-monitored goal-directed nutrition therapy is very important in the management of patients with alcohol-related ACLF along with SMT.”
Confirmatory Data
Reached for comment, Katherine Patton, MEd, RD, a registered dietitian with the Center for Human Nutrition at Cleveland Clinic, Cleveland, Ohio, said it’s well known that the ACLF patient population has a “very high rate of morbidity and mortality and their quality of life tends to be poor due to their frailty. It is also fairly well-known that proper nutrition therapy can improve outcomes, however barriers to adequate nutrition include decreased appetite, nausea, pain, altered taste, and early satiety from ascites.”
“Hepatologists are likely stressing the importance of adequate protein energy intake and doctors may refer patients to an outpatient dietitian, but it is up to the patient to make that appointment and act on the recommendations,” Patton told GI & Hepatology News.
“If a dietitian works in the same clinic as the hepatologist and patients can be referred and seen the same day, this is ideal. During a hospital admission, protein/calorie intake can be more closely monitored and encouraged by a multi-disciplinary team,” Patton explained.
She cautioned that “the average patient is not familiar with how to apply general calorie and protein goals to their everyday eating habits. This study amplifies the role of a dietitian and what consistent education and resources can do to improve a patient’s quality of life and survival.”
This study had no specific funding. The authors have declared no relevant conflicts of interest. Patton had no relevant disclosures.
A version of this article appeared on Medscape.com.
In a randomized controlled trial, compared with standard care, dietitian-supported, intensive nutritional therapy improved survival, reduced frailty, and lowered hospitalization rates in men with alcohol-related ACLF.
The study, performed by a team from the Postgraduate Institute of Medical Education and Research, Chandigarh, India, was published in Clinical Gastroenterology and Hepatology.
ACLF related to alcohol use is associated with poor outcomes due to poor nutritional intake and frailty. Frail patients with ACLF face higher morbidity, mortality, and hospitalization rates than their nonfrail counterparts. However, research on the role of structured nutritional interventions in improving these outcomes is limited.
Patal Giri, MBBS, MD, and colleagues enrolled 70 men with alcohol-related ACLF and frailty (liver frailty index [LFI] > 4.5) in a single-center, open-label study. Half were randomly allocated to an intervention group receiving outpatient intensive nutrition therapy (OINT) plus standard medical treatment (SMT) and half to a control group receiving SMT alone for 3 months.
The intervention group received a monitored high-calorie, high-protein, and salt-restricted diet as prescribed by a dedicated senior liver dietitian. The control group received regular nutritional recommendations and were managed for the ACLF-associated complications, without intervention or guidance by the study team.
After 3 months follow-up, overall survival (the primary outcome) was significantly improved in the OINT group compared with the control group (91.4% vs 57.1%), “suggesting that the improvement in nutrition status is associated with better survival,” the study team noted. Three patients died in the OINT group vs 15 in the SMT group.
OINT also led to a significant improvement in frailty, with LFI scores decreasing by an average of 0.93 in the intervention group vs 0.33 in the control group; 97% of patients improved from frail to prefrail status in the OINT group, whereas only 20% of patients improved in the SMT group.
The mean change in LFI of 0.93 with OINT is “well above the substantially clinically important difference” (change of 0.8) established in a previous study, the authors noted.
Significant improvements in weight and body mass index were also observed in the OINT group relative to the control group.
Liver disease severity, including model for end-stage liver disease (MELD) scores, showed greater improvement in the OINT group than in the control group (−8.7 vs −6.3 points from baseline to 3 months).
During the follow-up period, fewer patients in the intervention group than in the control group required a hospital stay (17% vs 45.7%).
Limitations of the study include the single-center design and the short follow-up period of 3 months, which limits long-term outcome assessment. Further, the study only included patients meeting Asia Pacific Association for Study of Liver criteria for ACLF, which does not include the patients with organ failure as defined by European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria. Patients with ACLF who had more severe disease (MELD score > 30 or AARC > 10) were also not included.
Despite these limitations, the authors said their study showed that “dietician-monitored goal-directed nutrition therapy is very important in the management of patients with alcohol-related ACLF along with SMT.”
Confirmatory Data
Reached for comment, Katherine Patton, MEd, RD, a registered dietitian with the Center for Human Nutrition at Cleveland Clinic, Cleveland, Ohio, said it’s well known that the ACLF patient population has a “very high rate of morbidity and mortality and their quality of life tends to be poor due to their frailty. It is also fairly well-known that proper nutrition therapy can improve outcomes, however barriers to adequate nutrition include decreased appetite, nausea, pain, altered taste, and early satiety from ascites.”
“Hepatologists are likely stressing the importance of adequate protein energy intake and doctors may refer patients to an outpatient dietitian, but it is up to the patient to make that appointment and act on the recommendations,” Patton told GI & Hepatology News.
“If a dietitian works in the same clinic as the hepatologist and patients can be referred and seen the same day, this is ideal. During a hospital admission, protein/calorie intake can be more closely monitored and encouraged by a multi-disciplinary team,” Patton explained.
She cautioned that “the average patient is not familiar with how to apply general calorie and protein goals to their everyday eating habits. This study amplifies the role of a dietitian and what consistent education and resources can do to improve a patient’s quality of life and survival.”
This study had no specific funding. The authors have declared no relevant conflicts of interest. Patton had no relevant disclosures.
A version of this article appeared on Medscape.com.
In a randomized controlled trial, compared with standard care, dietitian-supported, intensive nutritional therapy improved survival, reduced frailty, and lowered hospitalization rates in men with alcohol-related ACLF.
The study, performed by a team from the Postgraduate Institute of Medical Education and Research, Chandigarh, India, was published in Clinical Gastroenterology and Hepatology.
ACLF related to alcohol use is associated with poor outcomes due to poor nutritional intake and frailty. Frail patients with ACLF face higher morbidity, mortality, and hospitalization rates than their nonfrail counterparts. However, research on the role of structured nutritional interventions in improving these outcomes is limited.
Patal Giri, MBBS, MD, and colleagues enrolled 70 men with alcohol-related ACLF and frailty (liver frailty index [LFI] > 4.5) in a single-center, open-label study. Half were randomly allocated to an intervention group receiving outpatient intensive nutrition therapy (OINT) plus standard medical treatment (SMT) and half to a control group receiving SMT alone for 3 months.
The intervention group received a monitored high-calorie, high-protein, and salt-restricted diet as prescribed by a dedicated senior liver dietitian. The control group received regular nutritional recommendations and were managed for the ACLF-associated complications, without intervention or guidance by the study team.
After 3 months follow-up, overall survival (the primary outcome) was significantly improved in the OINT group compared with the control group (91.4% vs 57.1%), “suggesting that the improvement in nutrition status is associated with better survival,” the study team noted. Three patients died in the OINT group vs 15 in the SMT group.
OINT also led to a significant improvement in frailty, with LFI scores decreasing by an average of 0.93 in the intervention group vs 0.33 in the control group; 97% of patients improved from frail to prefrail status in the OINT group, whereas only 20% of patients improved in the SMT group.
The mean change in LFI of 0.93 with OINT is “well above the substantially clinically important difference” (change of 0.8) established in a previous study, the authors noted.
Significant improvements in weight and body mass index were also observed in the OINT group relative to the control group.
Liver disease severity, including model for end-stage liver disease (MELD) scores, showed greater improvement in the OINT group than in the control group (−8.7 vs −6.3 points from baseline to 3 months).
During the follow-up period, fewer patients in the intervention group than in the control group required a hospital stay (17% vs 45.7%).
Limitations of the study include the single-center design and the short follow-up period of 3 months, which limits long-term outcome assessment. Further, the study only included patients meeting Asia Pacific Association for Study of Liver criteria for ACLF, which does not include the patients with organ failure as defined by European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria. Patients with ACLF who had more severe disease (MELD score > 30 or AARC > 10) were also not included.
Despite these limitations, the authors said their study showed that “dietician-monitored goal-directed nutrition therapy is very important in the management of patients with alcohol-related ACLF along with SMT.”
Confirmatory Data
Reached for comment, Katherine Patton, MEd, RD, a registered dietitian with the Center for Human Nutrition at Cleveland Clinic, Cleveland, Ohio, said it’s well known that the ACLF patient population has a “very high rate of morbidity and mortality and their quality of life tends to be poor due to their frailty. It is also fairly well-known that proper nutrition therapy can improve outcomes, however barriers to adequate nutrition include decreased appetite, nausea, pain, altered taste, and early satiety from ascites.”
“Hepatologists are likely stressing the importance of adequate protein energy intake and doctors may refer patients to an outpatient dietitian, but it is up to the patient to make that appointment and act on the recommendations,” Patton told GI & Hepatology News.
“If a dietitian works in the same clinic as the hepatologist and patients can be referred and seen the same day, this is ideal. During a hospital admission, protein/calorie intake can be more closely monitored and encouraged by a multi-disciplinary team,” Patton explained.
She cautioned that “the average patient is not familiar with how to apply general calorie and protein goals to their everyday eating habits. This study amplifies the role of a dietitian and what consistent education and resources can do to improve a patient’s quality of life and survival.”
This study had no specific funding. The authors have declared no relevant conflicts of interest. Patton had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Better Prep, Better Scope: Task Force Updates Colonoscopy Bowel Prep Advice
The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.
“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.
Choice of Prep, Dosing and Timing, and Dietary Restrictions
When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.
In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.
The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.
The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.
Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.
The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.
How might these updated consensus recommendations change current clinical practice?
Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.”
He noted that the task force prefers the term “guidance” to “guidelines.”
New Quality Benchmark
The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.
They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.
Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.
Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”
Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”
Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”
“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.
“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.
The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.
‘Timely and Important’ Updates
Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.”
“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.
He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”
“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.
The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.
The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.
This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.
A version of this article first appeared on Medscape.com.
The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.
“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.
Choice of Prep, Dosing and Timing, and Dietary Restrictions
When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.
In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.
The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.
The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.
Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.
The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.
How might these updated consensus recommendations change current clinical practice?
Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.”
He noted that the task force prefers the term “guidance” to “guidelines.”
New Quality Benchmark
The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.
They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.
Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.
Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”
Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”
Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”
“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.
“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.
The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.
‘Timely and Important’ Updates
Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.”
“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.
He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”
“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.
The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.
The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.
This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.
A version of this article first appeared on Medscape.com.
The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.
“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.
Choice of Prep, Dosing and Timing, and Dietary Restrictions
When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.
In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.
The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.
The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.
Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.
The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.
How might these updated consensus recommendations change current clinical practice?
Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.”
He noted that the task force prefers the term “guidance” to “guidelines.”
New Quality Benchmark
The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.
They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.
Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.
Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”
Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”
Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”
“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.
“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.
The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.
‘Timely and Important’ Updates
Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.”
“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.
He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”
“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.
The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.
The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.
This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
Safety Profile of GLP-1s ‘Reassuring’ in Upper Endoscopy
according to a meta-analysis of more than 80,000 patients.
Safety profiles, however, were comparable across groups, suggesting that prolonged fasting may be a sufficient management strategy, instead of withholding GLP-1RAs, lead author Antonio Facciorusso, MD, PhD, of the University of Foggia, Italy, and colleagues reported.
“The impact of GLP-1RAs on slowing gastric motility has raised concerns in patients undergoing endoscopic procedures, particularly upper endoscopies,” the investigators wrote in Clinical Gastroenterology and Hepatology. “This is due to the perceived risk of aspiration of retained gastric contents in sedated patients and the decreased visibility of the gastric mucosa, which can reduce the diagnostic yield of the examination.”
The American Society of Anesthesiologists (ASA) recommends withholding GLP-1RAs before procedures or surgery, whereas AGA suggests an individualized approach, citing limited supporting data.
A previous meta-analysis reported that GLP-1RAs mildly delayed gastric emptying, but clinical relevance remained unclear.
The present meta-analysis aimed to clarify this uncertainty by analyzing 13 retrospective studies that involved 84,065 patients undergoing upper endoscopy. Outcomes were compared among GLP-1RA users vs non-users, including rates of retained gastric contents, aborted procedures, and adverse events.
Patients on GLP-1RAs had significantly higher rates of retained gastric contents than non-users (odds ratio [OR], 5.56), a finding that held steady (OR, 4.20) after adjusting for age, sex, diabetes, body mass index, and other therapies.
GLP-1RAs were also associated with an increased likelihood of aborted procedures (OR, 5.13; 1% vs. 0.3%) and a higher need for repeat endoscopies (OR, 2.19; 1% vs 2%); however, Facciorusso and colleagues noted that these events, in absolute terms, were relatively uncommon.
“The rate of aborted and repeat procedures in the included studies was low,” the investigators wrote. “This meant that only for every 110 patients undergoing upper endoscopy while in GLP-1RA therapy would we observe an aborted procedure and only for every 120 patients would we need to repeat the procedure.”
The overall safety profile of GLP-1RAs in the context of upper endoscopy remained largely reassuring, they added. Specifically, rates of bronchial aspiration were not significantly different between users and non-users. What’s more, no single study reported a statistically significant increase in major complications, including pulmonary adverse events, among GLP-1RA users.
According to Facciorusso and colleagues, these findings suggest that retained gastric contents do not appear to substantially heighten the risk of serious harm, though further prospective studies are needed.
“Our comprehensive analysis indicates that, while the use of GLP-1RA results in higher rates of [retained gastric contents], the actual clinical impact appears to be limited,” they wrote. “Therefore, there is no strong evidence to support the routine discontinuation of the drug before upper endoscopy procedures.”
Instead, they supported the AGA task force’s recommendation for an individualized approach, and not withholding GLP-1RAs unnecessarily, calling this “the best compromise.”
“Prolonging the duration of fasting for solids could represent the optimal approach in these patients, although this strategy requires further evaluation,” the investigators concluded.
The investigators disclosed no conflicts of interest.
according to a meta-analysis of more than 80,000 patients.
Safety profiles, however, were comparable across groups, suggesting that prolonged fasting may be a sufficient management strategy, instead of withholding GLP-1RAs, lead author Antonio Facciorusso, MD, PhD, of the University of Foggia, Italy, and colleagues reported.
“The impact of GLP-1RAs on slowing gastric motility has raised concerns in patients undergoing endoscopic procedures, particularly upper endoscopies,” the investigators wrote in Clinical Gastroenterology and Hepatology. “This is due to the perceived risk of aspiration of retained gastric contents in sedated patients and the decreased visibility of the gastric mucosa, which can reduce the diagnostic yield of the examination.”
The American Society of Anesthesiologists (ASA) recommends withholding GLP-1RAs before procedures or surgery, whereas AGA suggests an individualized approach, citing limited supporting data.
A previous meta-analysis reported that GLP-1RAs mildly delayed gastric emptying, but clinical relevance remained unclear.
The present meta-analysis aimed to clarify this uncertainty by analyzing 13 retrospective studies that involved 84,065 patients undergoing upper endoscopy. Outcomes were compared among GLP-1RA users vs non-users, including rates of retained gastric contents, aborted procedures, and adverse events.
Patients on GLP-1RAs had significantly higher rates of retained gastric contents than non-users (odds ratio [OR], 5.56), a finding that held steady (OR, 4.20) after adjusting for age, sex, diabetes, body mass index, and other therapies.
GLP-1RAs were also associated with an increased likelihood of aborted procedures (OR, 5.13; 1% vs. 0.3%) and a higher need for repeat endoscopies (OR, 2.19; 1% vs 2%); however, Facciorusso and colleagues noted that these events, in absolute terms, were relatively uncommon.
“The rate of aborted and repeat procedures in the included studies was low,” the investigators wrote. “This meant that only for every 110 patients undergoing upper endoscopy while in GLP-1RA therapy would we observe an aborted procedure and only for every 120 patients would we need to repeat the procedure.”
The overall safety profile of GLP-1RAs in the context of upper endoscopy remained largely reassuring, they added. Specifically, rates of bronchial aspiration were not significantly different between users and non-users. What’s more, no single study reported a statistically significant increase in major complications, including pulmonary adverse events, among GLP-1RA users.
According to Facciorusso and colleagues, these findings suggest that retained gastric contents do not appear to substantially heighten the risk of serious harm, though further prospective studies are needed.
“Our comprehensive analysis indicates that, while the use of GLP-1RA results in higher rates of [retained gastric contents], the actual clinical impact appears to be limited,” they wrote. “Therefore, there is no strong evidence to support the routine discontinuation of the drug before upper endoscopy procedures.”
Instead, they supported the AGA task force’s recommendation for an individualized approach, and not withholding GLP-1RAs unnecessarily, calling this “the best compromise.”
“Prolonging the duration of fasting for solids could represent the optimal approach in these patients, although this strategy requires further evaluation,” the investigators concluded.
The investigators disclosed no conflicts of interest.
according to a meta-analysis of more than 80,000 patients.
Safety profiles, however, were comparable across groups, suggesting that prolonged fasting may be a sufficient management strategy, instead of withholding GLP-1RAs, lead author Antonio Facciorusso, MD, PhD, of the University of Foggia, Italy, and colleagues reported.
“The impact of GLP-1RAs on slowing gastric motility has raised concerns in patients undergoing endoscopic procedures, particularly upper endoscopies,” the investigators wrote in Clinical Gastroenterology and Hepatology. “This is due to the perceived risk of aspiration of retained gastric contents in sedated patients and the decreased visibility of the gastric mucosa, which can reduce the diagnostic yield of the examination.”
The American Society of Anesthesiologists (ASA) recommends withholding GLP-1RAs before procedures or surgery, whereas AGA suggests an individualized approach, citing limited supporting data.
A previous meta-analysis reported that GLP-1RAs mildly delayed gastric emptying, but clinical relevance remained unclear.
The present meta-analysis aimed to clarify this uncertainty by analyzing 13 retrospective studies that involved 84,065 patients undergoing upper endoscopy. Outcomes were compared among GLP-1RA users vs non-users, including rates of retained gastric contents, aborted procedures, and adverse events.
Patients on GLP-1RAs had significantly higher rates of retained gastric contents than non-users (odds ratio [OR], 5.56), a finding that held steady (OR, 4.20) after adjusting for age, sex, diabetes, body mass index, and other therapies.
GLP-1RAs were also associated with an increased likelihood of aborted procedures (OR, 5.13; 1% vs. 0.3%) and a higher need for repeat endoscopies (OR, 2.19; 1% vs 2%); however, Facciorusso and colleagues noted that these events, in absolute terms, were relatively uncommon.
“The rate of aborted and repeat procedures in the included studies was low,” the investigators wrote. “This meant that only for every 110 patients undergoing upper endoscopy while in GLP-1RA therapy would we observe an aborted procedure and only for every 120 patients would we need to repeat the procedure.”
The overall safety profile of GLP-1RAs in the context of upper endoscopy remained largely reassuring, they added. Specifically, rates of bronchial aspiration were not significantly different between users and non-users. What’s more, no single study reported a statistically significant increase in major complications, including pulmonary adverse events, among GLP-1RA users.
According to Facciorusso and colleagues, these findings suggest that retained gastric contents do not appear to substantially heighten the risk of serious harm, though further prospective studies are needed.
“Our comprehensive analysis indicates that, while the use of GLP-1RA results in higher rates of [retained gastric contents], the actual clinical impact appears to be limited,” they wrote. “Therefore, there is no strong evidence to support the routine discontinuation of the drug before upper endoscopy procedures.”
Instead, they supported the AGA task force’s recommendation for an individualized approach, and not withholding GLP-1RAs unnecessarily, calling this “the best compromise.”
“Prolonging the duration of fasting for solids could represent the optimal approach in these patients, although this strategy requires further evaluation,” the investigators concluded.
The investigators disclosed no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Two Cystic Duct Stents Appear Better Than One
according to a retrospective multicenter study.
These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.
The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.
“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”
To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents.
The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions.
Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).
Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases.
Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.
Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).
Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.
“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”
The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.
according to a retrospective multicenter study.
These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.
The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.
“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”
To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents.
The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions.
Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).
Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases.
Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.
Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).
Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.
“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”
The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.
according to a retrospective multicenter study.
These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.
The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.
“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”
To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents.
The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions.
Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).
Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases.
Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.
Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).
Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.
“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”
The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.
FROM TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY
Circulating Proteins Predict Crohn’s Disease Years in Advance
The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported.
“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.
Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted.
Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.
First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature.
In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87.
While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.
Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.
“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”
These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.
Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs.
The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation.
In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.
Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.
“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.
This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.
Nowadays, preclinical biomarker discovery for inflammatory bowel diseases (IBD) is one of the key areas of study, aiming to identify the earliest stages of disease development and to find opportunities for early intervention. The study by Grännö and colleagues taps into this area and provides a significant advancement in the early detection of Crohn’s disease (CD) with a validated 29-plasma protein biomarker signature.
With an AUC of up to 0.87 in preclinical CD cases and even 0.82 as early as 16 years before diagnosis, these findings strongly support the notion that CD has a prolonged preclinical phase that is detectable up to many years before diagnosis. Importantly, their identified protein signatures also shed light on distinct pathophysiological mechanisms between CD and ulcerative colitis (UC), with CD characterized by early disruptions in gut barrier integrity and macrophage function, while UC was more marked by upregulated inflammatory markers.
For clinical practitioners, these findings have a strong transformative potential. Following further validation in larger cohorts and allowing clinical accessibility, preclinical biomarker screening could become a routine tool for risk stratification in at-risk individuals, such as those with a strong family history or genetic predisposition. This could enable implementation of early interventions, including dietary modifications and potentially prophylactic therapies, to delay or even prevent disease onset. Given that similar approaches have proven effective in type 1 diabetes, applying this strategy to IBD could significantly alter disease progression and patient outcomes.
Challenges remain before implementation in clinical practice could be realized. Standardized thresholds for risk assessment, cost-effectiveness analyses, and potential therapeutic strategies tailored to biomarker-positive individuals require further exploration. However, this study provides important data needed for a paradigm shift in IBD management — one that moves from reactive treatment to proactive prevention.
Arno R. Bourgonje, MD, PhD, is a postdoctoral fellow at the Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, and at the University Medical Center Groningen in Groningen, the Netherlands. He is involved in the European INTERCEPT consortium, which is focused on prediction and prevention of IBD. He reported no conflicts of interest.
Nowadays, preclinical biomarker discovery for inflammatory bowel diseases (IBD) is one of the key areas of study, aiming to identify the earliest stages of disease development and to find opportunities for early intervention. The study by Grännö and colleagues taps into this area and provides a significant advancement in the early detection of Crohn’s disease (CD) with a validated 29-plasma protein biomarker signature.
With an AUC of up to 0.87 in preclinical CD cases and even 0.82 as early as 16 years before diagnosis, these findings strongly support the notion that CD has a prolonged preclinical phase that is detectable up to many years before diagnosis. Importantly, their identified protein signatures also shed light on distinct pathophysiological mechanisms between CD and ulcerative colitis (UC), with CD characterized by early disruptions in gut barrier integrity and macrophage function, while UC was more marked by upregulated inflammatory markers.
For clinical practitioners, these findings have a strong transformative potential. Following further validation in larger cohorts and allowing clinical accessibility, preclinical biomarker screening could become a routine tool for risk stratification in at-risk individuals, such as those with a strong family history or genetic predisposition. This could enable implementation of early interventions, including dietary modifications and potentially prophylactic therapies, to delay or even prevent disease onset. Given that similar approaches have proven effective in type 1 diabetes, applying this strategy to IBD could significantly alter disease progression and patient outcomes.
Challenges remain before implementation in clinical practice could be realized. Standardized thresholds for risk assessment, cost-effectiveness analyses, and potential therapeutic strategies tailored to biomarker-positive individuals require further exploration. However, this study provides important data needed for a paradigm shift in IBD management — one that moves from reactive treatment to proactive prevention.
Arno R. Bourgonje, MD, PhD, is a postdoctoral fellow at the Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, and at the University Medical Center Groningen in Groningen, the Netherlands. He is involved in the European INTERCEPT consortium, which is focused on prediction and prevention of IBD. He reported no conflicts of interest.
Nowadays, preclinical biomarker discovery for inflammatory bowel diseases (IBD) is one of the key areas of study, aiming to identify the earliest stages of disease development and to find opportunities for early intervention. The study by Grännö and colleagues taps into this area and provides a significant advancement in the early detection of Crohn’s disease (CD) with a validated 29-plasma protein biomarker signature.
With an AUC of up to 0.87 in preclinical CD cases and even 0.82 as early as 16 years before diagnosis, these findings strongly support the notion that CD has a prolonged preclinical phase that is detectable up to many years before diagnosis. Importantly, their identified protein signatures also shed light on distinct pathophysiological mechanisms between CD and ulcerative colitis (UC), with CD characterized by early disruptions in gut barrier integrity and macrophage function, while UC was more marked by upregulated inflammatory markers.
For clinical practitioners, these findings have a strong transformative potential. Following further validation in larger cohorts and allowing clinical accessibility, preclinical biomarker screening could become a routine tool for risk stratification in at-risk individuals, such as those with a strong family history or genetic predisposition. This could enable implementation of early interventions, including dietary modifications and potentially prophylactic therapies, to delay or even prevent disease onset. Given that similar approaches have proven effective in type 1 diabetes, applying this strategy to IBD could significantly alter disease progression and patient outcomes.
Challenges remain before implementation in clinical practice could be realized. Standardized thresholds for risk assessment, cost-effectiveness analyses, and potential therapeutic strategies tailored to biomarker-positive individuals require further exploration. However, this study provides important data needed for a paradigm shift in IBD management — one that moves from reactive treatment to proactive prevention.
Arno R. Bourgonje, MD, PhD, is a postdoctoral fellow at the Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, and at the University Medical Center Groningen in Groningen, the Netherlands. He is involved in the European INTERCEPT consortium, which is focused on prediction and prevention of IBD. He reported no conflicts of interest.
The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported.
“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.
Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted.
Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.
First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature.
In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87.
While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.
Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.
“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”
These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.
Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs.
The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation.
In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.
Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.
“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.
This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.
The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported.
“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.
Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted.
Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.
First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature.
In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87.
While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.
Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.
“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”
These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.
Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs.
The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation.
In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.
Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.
“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.
This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.
FROM GASTROENTEROLOGY
Preventing Hepatitis B Reactivation: Updated Clinical Guidance From AGA
The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.
Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.
With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.
“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”
Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”
Main Recommendations
AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.
The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.
1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).
2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.
Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.
3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.
4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.
It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.
Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment
The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.
In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.
A ‘Useful Clinical Tool’
Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”
In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.
She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.
“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.
Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.
The Future
According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.
Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.
The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.
AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.
The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.
A version of this article appeared on Medscape.com.
The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.
Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.
With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.
“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”
Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”
Main Recommendations
AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.
The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.
1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).
2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.
Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.
3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.
4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.
It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.
Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment
The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.
In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.
A ‘Useful Clinical Tool’
Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”
In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.
She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.
“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.
Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.
The Future
According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.
Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.
The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.
AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.
The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.
A version of this article appeared on Medscape.com.
The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.
Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.
With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.
“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”
Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”
Main Recommendations
AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.
The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.
1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).
2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.
Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.
3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.
4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.
It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.
Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment
The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.
In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.
A ‘Useful Clinical Tool’
Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”
In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.
She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.
“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.
Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.
The Future
According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.
Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.
The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.
AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.
The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Choosing the Ideal Endoscopic Enteral Access Method: AGA Practice Update
At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this,
Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.
“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”
Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.
There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.
He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”
The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.
Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”
Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”
Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.
“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.
Tubing Options
According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.
The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.
Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.
Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”
She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.
Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.
Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.
A version of this article appeared on Medscape.com.
At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this,
Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.
“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”
Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.
There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.
He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”
The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.
Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”
Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”
Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.
“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.
Tubing Options
According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.
The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.
Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.
Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”
She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.
Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.
Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.
A version of this article appeared on Medscape.com.
At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this,
Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.
“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”
Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.
There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.
He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”
The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.
Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”
Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”
Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.
“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.
Tubing Options
According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.
The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.
Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.
Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”
She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.
Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.
Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Navigating Esophageal Dysfunction in Immune and Infectious Disorders: AGA Clinical Practice Update
“Many different disorders can lead to esophageal dysfunction, which is characterized by symptoms including dysphagia, odynophagia, chest pain and heartburn. These symptoms can be caused either by immune or infectious conditions and can either be localized to the esophagus or part of a larger systemic process,” co–first author Emily McGowan, MD, PhD, with the division of allergy and immunology, University of Virginia School of Medicine, Charlottesville, said in an AGA podcast.
However, without a “high index of suspicion,” these conditions can be overlooked, leading to delays in diagnosis and unnecessary procedures. “With this clinical practice update, we wanted to help providers more readily recognize these conditions so that patients can be diagnosed and treated earlier in the course of their disease,” McGowan explained.
“This is a fantastic review that highlights how many different systemic disorders can affect the esophagus,” Scott Gabbard, MD, gastroenterologist and section head at the Center for Neurogastroenterology and Motility, Cleveland Clinic, Ohio, who wasn’t involved in the review, said in an interview.
“Honestly, for the practicing gastroenterologist, this is one of those reviews that I could envision someone either saving to his or her desktop for reference or printing it and pinning it next to his or her desk,” Gabbard said.
Best Practice Advice
The clinical practice update is published in Clinical Gastroenterology and Hepatology. It includes 10 “best practice advice” statements and a table highlighting “important” considerations when evaluating patients with esophageal dysfunction.
The review authors note that esophageal dysfunction may result from localized infections — most commonly Candida, herpes simplex virus, and cytomegalovirus — or systemic immune-mediated diseases, such as systemic sclerosis (SSc), mixed connective tissue disease (MCTD), and eosinophilic esophagitis (EoE).
They advise clinicians to identify if there are risks for inflammatory or infectious possibilities for a patient’s esophageal symptoms and investigate for these disorders as a potential cause of esophageal dysfunction.
Once esophageal infection is identified, it’s important to identify whether accompanying signs and symptoms point to immunocompromise leading to a more systemic infection. Consultation with an infectious disease expert is recommended to guide appropriate treatment, the authors said.
If symptoms fail to improve after therapy for infectious esophagitis, the patient should be evaluated for refractory infection or additional underlying sources of esophageal and immunologic dysfunction is advised.
It’s also important to recognize that patients with EoE who continue to have symptoms of esophageal dysfunction despite histologic and endoscopic disease remission, may develop a motility disorder and evaluation of esophageal motility may be warranted, the authors said.
In patients with histologic and endoscopic features of lymphocytic esophagitis, treatment of lymphocytic-related inflammation with proton-pump inhibitor (PPI) therapy or swallowed topical corticosteroids and esophageal dilation as needed should be considered.
In patients who present with esophageal symptoms in the setting of hypereosinophilia (absolute eosinophil count > 1500 cells/uL), the authors advise further workup of non-EoE eosinophilic gastrointestinal disease, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis should be considered, with consultation with an allergy/immunology specialist if helpful.
In patients with rheumatologic diseases, especially SSc and MCTD, it’s important to be aware that esophageal symptoms can occur because of involvement of the esophageal muscle layer, resulting in dysmotility and/or incompetence of the lower esophageal sphincter, they said.
In the setting of Crohn’s disease, some patients can develop esophageal involvement from inflammation, stricturing, or fistulizing changes with granulomas seen histologically. Esophageal manifestations of Crohn’s disease tend to occur in patients with active intestinal disease.
In patients with dermatologic diseases of lichen planus or bullous disorders, dysphagia can occur because of endoscopically visible esophageal mucosal involvement. Esophageal lichen planus, in particular, can occur without skin involvement and can be difficult to define on esophageal histopathology.
The authors also advise clinicians to consider infectious and inflammatory causes of secondary achalasia during initial evaluation.
“Achalasia and EoE might coexist more commonly than what gastroenterologists think, especially in younger patients,” co–first author Chanakyaram Reddy, MD, a gastroenterologist with Baylor University Medical Center, Dallas, Texas, said in the AGA podcast.
He noted that in a recent population-based study, the estimated relative risk of EoE was over 30-fold higher in patients with achalasia aged ≤ 40 years.
“In any suspected achalasia case, it would be wise to obtain biopsies throughout the entire esophagus when the patient is off confounding medications such as PPI therapy to establish if significant esophageal eosinophilia is coexistent,” Reddy said.
“If EoE-level eosinophilia is found, it would be reasonable to consider treating medically for EoE prior to committing to achalasia-specific interventions, which often involve permanent disruption of the esophageal muscle layer,” he added.
Gabbard said this review helps the clinician think beyond gastroesophageal reflux disease (GERD) — the most common cause of esophageal dysfunction — and consider other causes for esophageal dysfunction.
“We are seeing more complex disorders affect the esophagus. It’s not just GERD and you absolutely need a high index of suspicion because you can find varying disorders to blame for many esophageal symptoms that could otherwise be thought to be just reflux,” he said.
This research had no commercial funding. Disclosures for the authors are listed with the original article. Gabbard had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Many different disorders can lead to esophageal dysfunction, which is characterized by symptoms including dysphagia, odynophagia, chest pain and heartburn. These symptoms can be caused either by immune or infectious conditions and can either be localized to the esophagus or part of a larger systemic process,” co–first author Emily McGowan, MD, PhD, with the division of allergy and immunology, University of Virginia School of Medicine, Charlottesville, said in an AGA podcast.
However, without a “high index of suspicion,” these conditions can be overlooked, leading to delays in diagnosis and unnecessary procedures. “With this clinical practice update, we wanted to help providers more readily recognize these conditions so that patients can be diagnosed and treated earlier in the course of their disease,” McGowan explained.
“This is a fantastic review that highlights how many different systemic disorders can affect the esophagus,” Scott Gabbard, MD, gastroenterologist and section head at the Center for Neurogastroenterology and Motility, Cleveland Clinic, Ohio, who wasn’t involved in the review, said in an interview.
“Honestly, for the practicing gastroenterologist, this is one of those reviews that I could envision someone either saving to his or her desktop for reference or printing it and pinning it next to his or her desk,” Gabbard said.
Best Practice Advice
The clinical practice update is published in Clinical Gastroenterology and Hepatology. It includes 10 “best practice advice” statements and a table highlighting “important” considerations when evaluating patients with esophageal dysfunction.
The review authors note that esophageal dysfunction may result from localized infections — most commonly Candida, herpes simplex virus, and cytomegalovirus — or systemic immune-mediated diseases, such as systemic sclerosis (SSc), mixed connective tissue disease (MCTD), and eosinophilic esophagitis (EoE).
They advise clinicians to identify if there are risks for inflammatory or infectious possibilities for a patient’s esophageal symptoms and investigate for these disorders as a potential cause of esophageal dysfunction.
Once esophageal infection is identified, it’s important to identify whether accompanying signs and symptoms point to immunocompromise leading to a more systemic infection. Consultation with an infectious disease expert is recommended to guide appropriate treatment, the authors said.
If symptoms fail to improve after therapy for infectious esophagitis, the patient should be evaluated for refractory infection or additional underlying sources of esophageal and immunologic dysfunction is advised.
It’s also important to recognize that patients with EoE who continue to have symptoms of esophageal dysfunction despite histologic and endoscopic disease remission, may develop a motility disorder and evaluation of esophageal motility may be warranted, the authors said.
In patients with histologic and endoscopic features of lymphocytic esophagitis, treatment of lymphocytic-related inflammation with proton-pump inhibitor (PPI) therapy or swallowed topical corticosteroids and esophageal dilation as needed should be considered.
In patients who present with esophageal symptoms in the setting of hypereosinophilia (absolute eosinophil count > 1500 cells/uL), the authors advise further workup of non-EoE eosinophilic gastrointestinal disease, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis should be considered, with consultation with an allergy/immunology specialist if helpful.
In patients with rheumatologic diseases, especially SSc and MCTD, it’s important to be aware that esophageal symptoms can occur because of involvement of the esophageal muscle layer, resulting in dysmotility and/or incompetence of the lower esophageal sphincter, they said.
In the setting of Crohn’s disease, some patients can develop esophageal involvement from inflammation, stricturing, or fistulizing changes with granulomas seen histologically. Esophageal manifestations of Crohn’s disease tend to occur in patients with active intestinal disease.
In patients with dermatologic diseases of lichen planus or bullous disorders, dysphagia can occur because of endoscopically visible esophageal mucosal involvement. Esophageal lichen planus, in particular, can occur without skin involvement and can be difficult to define on esophageal histopathology.
The authors also advise clinicians to consider infectious and inflammatory causes of secondary achalasia during initial evaluation.
“Achalasia and EoE might coexist more commonly than what gastroenterologists think, especially in younger patients,” co–first author Chanakyaram Reddy, MD, a gastroenterologist with Baylor University Medical Center, Dallas, Texas, said in the AGA podcast.
He noted that in a recent population-based study, the estimated relative risk of EoE was over 30-fold higher in patients with achalasia aged ≤ 40 years.
“In any suspected achalasia case, it would be wise to obtain biopsies throughout the entire esophagus when the patient is off confounding medications such as PPI therapy to establish if significant esophageal eosinophilia is coexistent,” Reddy said.
“If EoE-level eosinophilia is found, it would be reasonable to consider treating medically for EoE prior to committing to achalasia-specific interventions, which often involve permanent disruption of the esophageal muscle layer,” he added.
Gabbard said this review helps the clinician think beyond gastroesophageal reflux disease (GERD) — the most common cause of esophageal dysfunction — and consider other causes for esophageal dysfunction.
“We are seeing more complex disorders affect the esophagus. It’s not just GERD and you absolutely need a high index of suspicion because you can find varying disorders to blame for many esophageal symptoms that could otherwise be thought to be just reflux,” he said.
This research had no commercial funding. Disclosures for the authors are listed with the original article. Gabbard had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Many different disorders can lead to esophageal dysfunction, which is characterized by symptoms including dysphagia, odynophagia, chest pain and heartburn. These symptoms can be caused either by immune or infectious conditions and can either be localized to the esophagus or part of a larger systemic process,” co–first author Emily McGowan, MD, PhD, with the division of allergy and immunology, University of Virginia School of Medicine, Charlottesville, said in an AGA podcast.
However, without a “high index of suspicion,” these conditions can be overlooked, leading to delays in diagnosis and unnecessary procedures. “With this clinical practice update, we wanted to help providers more readily recognize these conditions so that patients can be diagnosed and treated earlier in the course of their disease,” McGowan explained.
“This is a fantastic review that highlights how many different systemic disorders can affect the esophagus,” Scott Gabbard, MD, gastroenterologist and section head at the Center for Neurogastroenterology and Motility, Cleveland Clinic, Ohio, who wasn’t involved in the review, said in an interview.
“Honestly, for the practicing gastroenterologist, this is one of those reviews that I could envision someone either saving to his or her desktop for reference or printing it and pinning it next to his or her desk,” Gabbard said.
Best Practice Advice
The clinical practice update is published in Clinical Gastroenterology and Hepatology. It includes 10 “best practice advice” statements and a table highlighting “important” considerations when evaluating patients with esophageal dysfunction.
The review authors note that esophageal dysfunction may result from localized infections — most commonly Candida, herpes simplex virus, and cytomegalovirus — or systemic immune-mediated diseases, such as systemic sclerosis (SSc), mixed connective tissue disease (MCTD), and eosinophilic esophagitis (EoE).
They advise clinicians to identify if there are risks for inflammatory or infectious possibilities for a patient’s esophageal symptoms and investigate for these disorders as a potential cause of esophageal dysfunction.
Once esophageal infection is identified, it’s important to identify whether accompanying signs and symptoms point to immunocompromise leading to a more systemic infection. Consultation with an infectious disease expert is recommended to guide appropriate treatment, the authors said.
If symptoms fail to improve after therapy for infectious esophagitis, the patient should be evaluated for refractory infection or additional underlying sources of esophageal and immunologic dysfunction is advised.
It’s also important to recognize that patients with EoE who continue to have symptoms of esophageal dysfunction despite histologic and endoscopic disease remission, may develop a motility disorder and evaluation of esophageal motility may be warranted, the authors said.
In patients with histologic and endoscopic features of lymphocytic esophagitis, treatment of lymphocytic-related inflammation with proton-pump inhibitor (PPI) therapy or swallowed topical corticosteroids and esophageal dilation as needed should be considered.
In patients who present with esophageal symptoms in the setting of hypereosinophilia (absolute eosinophil count > 1500 cells/uL), the authors advise further workup of non-EoE eosinophilic gastrointestinal disease, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis should be considered, with consultation with an allergy/immunology specialist if helpful.
In patients with rheumatologic diseases, especially SSc and MCTD, it’s important to be aware that esophageal symptoms can occur because of involvement of the esophageal muscle layer, resulting in dysmotility and/or incompetence of the lower esophageal sphincter, they said.
In the setting of Crohn’s disease, some patients can develop esophageal involvement from inflammation, stricturing, or fistulizing changes with granulomas seen histologically. Esophageal manifestations of Crohn’s disease tend to occur in patients with active intestinal disease.
In patients with dermatologic diseases of lichen planus or bullous disorders, dysphagia can occur because of endoscopically visible esophageal mucosal involvement. Esophageal lichen planus, in particular, can occur without skin involvement and can be difficult to define on esophageal histopathology.
The authors also advise clinicians to consider infectious and inflammatory causes of secondary achalasia during initial evaluation.
“Achalasia and EoE might coexist more commonly than what gastroenterologists think, especially in younger patients,” co–first author Chanakyaram Reddy, MD, a gastroenterologist with Baylor University Medical Center, Dallas, Texas, said in the AGA podcast.
He noted that in a recent population-based study, the estimated relative risk of EoE was over 30-fold higher in patients with achalasia aged ≤ 40 years.
“In any suspected achalasia case, it would be wise to obtain biopsies throughout the entire esophagus when the patient is off confounding medications such as PPI therapy to establish if significant esophageal eosinophilia is coexistent,” Reddy said.
“If EoE-level eosinophilia is found, it would be reasonable to consider treating medically for EoE prior to committing to achalasia-specific interventions, which often involve permanent disruption of the esophageal muscle layer,” he added.
Gabbard said this review helps the clinician think beyond gastroesophageal reflux disease (GERD) — the most common cause of esophageal dysfunction — and consider other causes for esophageal dysfunction.
“We are seeing more complex disorders affect the esophagus. It’s not just GERD and you absolutely need a high index of suspicion because you can find varying disorders to blame for many esophageal symptoms that could otherwise be thought to be just reflux,” he said.
This research had no commercial funding. Disclosures for the authors are listed with the original article. Gabbard had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Best Practices When Using POEM to Treat Achalasia: AGA Clinical Update
The American Gastroenterological Association (AGA) has released
“Any patient suspected to have achalasia, or difficulty swallowing for that matter, should undergo a comprehensive diagnostic workup, and that should include clinical history, review of medication, as well as tests. The diagnosis should not be based on isolated tests but on the clinical picture as a whole,” first author Dennis Yang, MD, AGAF, with the Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, noted in an AGA podcast about the update.
The clinical practice update, published in Gastroenterology, includes 12 “best practice advice” statements.
Since its introduction to clinical practice more than a decade ago, POEM has matured and gained widespread acceptance because of its efficacy and safety profile.
POEM has at least similar outcomes to laparoscopic Heller myotomy and pneumatic dilation for type I and type II achalasia with better results for those with type III achalasia, Yang noted.
“However, besides disease phenotype, we need to remember that choosing the right treatment for the patient is going to be based on multiple factors including patient characteristics as well as local expertise,” Yang added.
In terms of technical considerations, the update states that both anterior and posterior tunnel approaches demonstrate comparable success and postprocedure reflux rates. Tunnel orientation should be tailored to the patient’s surgical history and endoscopist’s preference.
It further states that optimal length of the myotomy in the esophagus and cardia, as it pertains to treatment efficacy and risk for postprocedure reflux, remains to be determined.
Adjunct techniques, including real-time intraprocedure functional luminal impedance planimetry, may be considered to tailor or confirm the adequacy of the myotomy.
Same-day discharge after POEM can be considered in select patients who meet discharge criteria. Patients with advanced age, significant comorbidities, poor social support, and/or access to specialized care should be considered for hospital admission, irrespective of symptoms.
The update notes that specific guidelines on the role and extent of antibiotic prophylaxis before and after POEM are lacking. A single dose of antibiotics at the time of POEM “may be sufficient” for antibiotic prophylaxis.
In terms of immediate post-POEM care, the update notes that the clinical impact of routine esophagram or endoscopy immediately post-POEM remains unclear. Testing can be considered based on local practice preferences and in cases in which intraprocedural events or postprocedural findings warrant further evaluation.
Proton pump inhibitors are recommended immediately following POEM, as gastroesophageal reflux disease (GERD) is common following POEM, occurring in up to 65% of cases.
Routine endoscopic surveillance is advised to monitor GERD, disease progression, and esophageal cancer risk, which is significantly higher in achalasia patients.
“Just like diabetes and hypertension, we need to remember that achalasia is a chronic disease and long-term postprocedural surveillance is strongly encouraged to monitor disease progression as well as potential complications of reflux,” Yang said.
He noted that surveillance should be considered irrespective of patient symptoms because many of these patients may remain asymptomatic.
“Primary gastroenterologists should have a very low threshold in referring the patient back to the POEM endoscopist or any specialized esophageal center because the ideology of symptoms in these patients can be quite difficult to tease out and often require comprehensive diagnostic workup,” Yang said.
Evidence for POEM in esophagogastric outflow obstruction and other nonachalasia spastic motility disorders is limited and should only be considered on a case-by-case basis after other less invasive approaches have been exhausted, the update states.
For perspective on the POEM clinical practice update, this news organization spoke with Mouen Khashab, MD, director of therapeutic endoscopy, Johns Hopkins University, Baltimore, Maryland.
“The document is very well written and comprehensive,” Khashab said.
However, Khashab said he would have liked to see greater emphasis on the value or role of a short myotomy in the esophagus and cardia.
“There is level I evidence that the short esophageal myotomy is equivalent to a long esophageal myotomy for type I and II achalasia. When you do a short myotomy, you save procedure time and there is potentially a lower incidence of blown-out myotomy or BOM,” Khashab said.
Khashab also noted that a long myotomy on the gastric side “likely increases the risk of reflux disease, and therefore a limited myotomy on the gastric side likely also is advantageous.”
This research had no commercial funding. Yang serves as a consultant for Boston Scientific, Olympus, FujiFilm, Microtech, Medtronic, 3D-Matrix, and Neptune Medical, and has received research support from Microtech and 3D-Matrix. Khashab had no relevant disclosures.
A version of this article appeared on Medscape.com .
The American Gastroenterological Association (AGA) has released
“Any patient suspected to have achalasia, or difficulty swallowing for that matter, should undergo a comprehensive diagnostic workup, and that should include clinical history, review of medication, as well as tests. The diagnosis should not be based on isolated tests but on the clinical picture as a whole,” first author Dennis Yang, MD, AGAF, with the Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, noted in an AGA podcast about the update.
The clinical practice update, published in Gastroenterology, includes 12 “best practice advice” statements.
Since its introduction to clinical practice more than a decade ago, POEM has matured and gained widespread acceptance because of its efficacy and safety profile.
POEM has at least similar outcomes to laparoscopic Heller myotomy and pneumatic dilation for type I and type II achalasia with better results for those with type III achalasia, Yang noted.
“However, besides disease phenotype, we need to remember that choosing the right treatment for the patient is going to be based on multiple factors including patient characteristics as well as local expertise,” Yang added.
In terms of technical considerations, the update states that both anterior and posterior tunnel approaches demonstrate comparable success and postprocedure reflux rates. Tunnel orientation should be tailored to the patient’s surgical history and endoscopist’s preference.
It further states that optimal length of the myotomy in the esophagus and cardia, as it pertains to treatment efficacy and risk for postprocedure reflux, remains to be determined.
Adjunct techniques, including real-time intraprocedure functional luminal impedance planimetry, may be considered to tailor or confirm the adequacy of the myotomy.
Same-day discharge after POEM can be considered in select patients who meet discharge criteria. Patients with advanced age, significant comorbidities, poor social support, and/or access to specialized care should be considered for hospital admission, irrespective of symptoms.
The update notes that specific guidelines on the role and extent of antibiotic prophylaxis before and after POEM are lacking. A single dose of antibiotics at the time of POEM “may be sufficient” for antibiotic prophylaxis.
In terms of immediate post-POEM care, the update notes that the clinical impact of routine esophagram or endoscopy immediately post-POEM remains unclear. Testing can be considered based on local practice preferences and in cases in which intraprocedural events or postprocedural findings warrant further evaluation.
Proton pump inhibitors are recommended immediately following POEM, as gastroesophageal reflux disease (GERD) is common following POEM, occurring in up to 65% of cases.
Routine endoscopic surveillance is advised to monitor GERD, disease progression, and esophageal cancer risk, which is significantly higher in achalasia patients.
“Just like diabetes and hypertension, we need to remember that achalasia is a chronic disease and long-term postprocedural surveillance is strongly encouraged to monitor disease progression as well as potential complications of reflux,” Yang said.
He noted that surveillance should be considered irrespective of patient symptoms because many of these patients may remain asymptomatic.
“Primary gastroenterologists should have a very low threshold in referring the patient back to the POEM endoscopist or any specialized esophageal center because the ideology of symptoms in these patients can be quite difficult to tease out and often require comprehensive diagnostic workup,” Yang said.
Evidence for POEM in esophagogastric outflow obstruction and other nonachalasia spastic motility disorders is limited and should only be considered on a case-by-case basis after other less invasive approaches have been exhausted, the update states.
For perspective on the POEM clinical practice update, this news organization spoke with Mouen Khashab, MD, director of therapeutic endoscopy, Johns Hopkins University, Baltimore, Maryland.
“The document is very well written and comprehensive,” Khashab said.
However, Khashab said he would have liked to see greater emphasis on the value or role of a short myotomy in the esophagus and cardia.
“There is level I evidence that the short esophageal myotomy is equivalent to a long esophageal myotomy for type I and II achalasia. When you do a short myotomy, you save procedure time and there is potentially a lower incidence of blown-out myotomy or BOM,” Khashab said.
Khashab also noted that a long myotomy on the gastric side “likely increases the risk of reflux disease, and therefore a limited myotomy on the gastric side likely also is advantageous.”
This research had no commercial funding. Yang serves as a consultant for Boston Scientific, Olympus, FujiFilm, Microtech, Medtronic, 3D-Matrix, and Neptune Medical, and has received research support from Microtech and 3D-Matrix. Khashab had no relevant disclosures.
A version of this article appeared on Medscape.com .
The American Gastroenterological Association (AGA) has released
“Any patient suspected to have achalasia, or difficulty swallowing for that matter, should undergo a comprehensive diagnostic workup, and that should include clinical history, review of medication, as well as tests. The diagnosis should not be based on isolated tests but on the clinical picture as a whole,” first author Dennis Yang, MD, AGAF, with the Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, noted in an AGA podcast about the update.
The clinical practice update, published in Gastroenterology, includes 12 “best practice advice” statements.
Since its introduction to clinical practice more than a decade ago, POEM has matured and gained widespread acceptance because of its efficacy and safety profile.
POEM has at least similar outcomes to laparoscopic Heller myotomy and pneumatic dilation for type I and type II achalasia with better results for those with type III achalasia, Yang noted.
“However, besides disease phenotype, we need to remember that choosing the right treatment for the patient is going to be based on multiple factors including patient characteristics as well as local expertise,” Yang added.
In terms of technical considerations, the update states that both anterior and posterior tunnel approaches demonstrate comparable success and postprocedure reflux rates. Tunnel orientation should be tailored to the patient’s surgical history and endoscopist’s preference.
It further states that optimal length of the myotomy in the esophagus and cardia, as it pertains to treatment efficacy and risk for postprocedure reflux, remains to be determined.
Adjunct techniques, including real-time intraprocedure functional luminal impedance planimetry, may be considered to tailor or confirm the adequacy of the myotomy.
Same-day discharge after POEM can be considered in select patients who meet discharge criteria. Patients with advanced age, significant comorbidities, poor social support, and/or access to specialized care should be considered for hospital admission, irrespective of symptoms.
The update notes that specific guidelines on the role and extent of antibiotic prophylaxis before and after POEM are lacking. A single dose of antibiotics at the time of POEM “may be sufficient” for antibiotic prophylaxis.
In terms of immediate post-POEM care, the update notes that the clinical impact of routine esophagram or endoscopy immediately post-POEM remains unclear. Testing can be considered based on local practice preferences and in cases in which intraprocedural events or postprocedural findings warrant further evaluation.
Proton pump inhibitors are recommended immediately following POEM, as gastroesophageal reflux disease (GERD) is common following POEM, occurring in up to 65% of cases.
Routine endoscopic surveillance is advised to monitor GERD, disease progression, and esophageal cancer risk, which is significantly higher in achalasia patients.
“Just like diabetes and hypertension, we need to remember that achalasia is a chronic disease and long-term postprocedural surveillance is strongly encouraged to monitor disease progression as well as potential complications of reflux,” Yang said.
He noted that surveillance should be considered irrespective of patient symptoms because many of these patients may remain asymptomatic.
“Primary gastroenterologists should have a very low threshold in referring the patient back to the POEM endoscopist or any specialized esophageal center because the ideology of symptoms in these patients can be quite difficult to tease out and often require comprehensive diagnostic workup,” Yang said.
Evidence for POEM in esophagogastric outflow obstruction and other nonachalasia spastic motility disorders is limited and should only be considered on a case-by-case basis after other less invasive approaches have been exhausted, the update states.
For perspective on the POEM clinical practice update, this news organization spoke with Mouen Khashab, MD, director of therapeutic endoscopy, Johns Hopkins University, Baltimore, Maryland.
“The document is very well written and comprehensive,” Khashab said.
However, Khashab said he would have liked to see greater emphasis on the value or role of a short myotomy in the esophagus and cardia.
“There is level I evidence that the short esophageal myotomy is equivalent to a long esophageal myotomy for type I and II achalasia. When you do a short myotomy, you save procedure time and there is potentially a lower incidence of blown-out myotomy or BOM,” Khashab said.
Khashab also noted that a long myotomy on the gastric side “likely increases the risk of reflux disease, and therefore a limited myotomy on the gastric side likely also is advantageous.”
This research had no commercial funding. Yang serves as a consultant for Boston Scientific, Olympus, FujiFilm, Microtech, Medtronic, 3D-Matrix, and Neptune Medical, and has received research support from Microtech and 3D-Matrix. Khashab had no relevant disclosures.
A version of this article appeared on Medscape.com .
FROM GASTROENTEROLOGY
New Risk Score Might Improve HCC Surveillance Among Cirrhosis Patients
, based to a recent phase 3 biomarker validation study.
The Prognostic Liver Secretome Signature with Alpha-Fetoprotein plus Age, Male Sex, Albumin-Bilirubin, and Platelets (PAaM) score integrates both molecular and clinical variables to effectively classify cirrhosis patients by their risk of developing HCC, potentially sparing low-risk patients from unnecessary surveillance, lead author Naoto Fujiwara, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, and colleagues reported.
“Hepatocellular carcinoma risk stratification is an urgent unmet need for cost-effective screening and early detection in patients with cirrhosis,” the investigators wrote in Gastroenterology. “This study represents the largest and first phase 3 biomarker validation study that establishes an integrative molecular/clinical score, PAaM, for HCC risk stratification.”
The PAaM score combines an 8-protein prognostic liver secretome signature with traditional clinical variables, including alpha-fetoprotein (AFP) levels, age, sex, albumin-bilirubin levels, and platelet counts. The score stratifies patients into high-, intermediate-, and low-risk categories.
The PAaM score was validated using 2 independent prospective cohorts in the United States: the statewide Texas Hepatocellular Carcinoma Consortium (THCCC) and the nationwide Hepatocellular Carcinoma Early Detection Strategy (HEDS). Across both cohorts, 3,484 patients with cirrhosis were followed over time to assess the development of HCC.
In the Texas cohort, comprising 2,156 patients with cirrhosis, PAaM classified 19% of patients as high risk, 42% as intermediate risk, and 39% as low risk. The annual incidence of HCC was significantly different across these groups, with high-risk patients experiencing a 5.3% incidence rate, versus 2.7% for intermediate-risk patients and 0.6% for low-risk patients (P less than .001). Compared with those in the low-risk group, high-risk patients had sub-distribution hazard ratio (sHR) of 7.51 for developing HCC, while intermediate-risk patients had an sHR of 4.20.
In the nationwide HEDS cohort, which included 1,328 patients, PAaM similarly stratified 15% of participants as high risk, 41% as intermediate risk, and 44% as low risk. Annual HCC incidence rates were 6.2%, 1.8%, and 0.8% for high-, intermediate-, and low-risk patients, respectively (P less than .001). Among these patients, sub-distribution hazard ratios for HCC were 6.54 for high-risk patients and 1.77 for intermediate-risk patients, again underscoring the tool’s potential to identify individuals at elevated risk of developing HCC.
The PAaM score outperformed existing models like the aMAP score and the PLSec-AFP molecular marker alone, with consistent superiority across a diverse range of cirrhosis etiologies, including metabolic dysfunction–associated steatotic liver disease (MASLD), alcohol-associated liver disease (ALD), and cured hepatitis C virus (HCV) infection.
Based on these findings, high-risk patients might benefit from more intensive screening strategies, Fujiwara and colleagues suggested, while intermediate-risk patients could continue with semi-annual ultrasound-based screening. Of note, low-risk patients—comprising about 40% of the study population—could potentially avoid frequent screenings, thus reducing healthcare costs and minimizing unnecessary interventions.
“This represents a significant step toward the clinical translation of an individual risk-based HCC screening strategy to improve early HCC detection and reduce HCC mortality,” the investigators concluded.This study was supported by various the National Cancer Institute, Veterans Affairs, the Japan Society for the Promotion of Science, and others. The investigators disclosed additional relationships with Boston Scientific, Sirtex, Bayer, and others.
Nancy S. Reau, MD, AGAF, of RUSH University in Chicago, highlighted both the promise and challenges of the PAaM score for HCC risk stratification, emphasizing that current liver cancer screening strategies remain inadequate, with only about 25% of patients receiving guideline-recommended surveillance.
“An easy-to-apply cost effective tool could significantly improve screening strategies, which should lead to earlier identification of liver cancer—at a time when curative treatment options are available,” Reau said.
PAaM, however, may be impractical for routine use.
“A tool that classifies people into 3 different screening strategies and requires longitudinal applications and re-classification could add complexity,” she explained, predicting that “clinicians aren’t going to use it correctly.
Reau was particularly concerned about the need for repeated assessments over time.
“People change,” she said. “A low-risk categorization by PAaM at the age of 40 may no longer be relevant at 50 or 60 as liver disease progresses.”
Although the tool is “exciting,” Reau suggested that it is also “premature” until appropriate reclassification intervals are understood.
She also noted that some patients still develop HCC despite being considered low risk, including cases of HCC that develop in non-cirrhotic HCV infection or MASLD.
Beyond the above clinical considerations, Dr. Reau pointed out several barriers to implementing PAaM in routine practice, starting with the under-recognition of cirrhosis. Even if patients are identified, ensuring both clinicians and patients adhere to screening recommendations remains a challenge.
Finally, financial considerations may pose obstacles.
“If some payers cover the tool and others do not, it will be very difficult to implement,” Dr. Reau concluded.
Reau reported no conflicts of interest.
Nancy S. Reau, MD, AGAF, of RUSH University in Chicago, highlighted both the promise and challenges of the PAaM score for HCC risk stratification, emphasizing that current liver cancer screening strategies remain inadequate, with only about 25% of patients receiving guideline-recommended surveillance.
“An easy-to-apply cost effective tool could significantly improve screening strategies, which should lead to earlier identification of liver cancer—at a time when curative treatment options are available,” Reau said.
PAaM, however, may be impractical for routine use.
“A tool that classifies people into 3 different screening strategies and requires longitudinal applications and re-classification could add complexity,” she explained, predicting that “clinicians aren’t going to use it correctly.
Reau was particularly concerned about the need for repeated assessments over time.
“People change,” she said. “A low-risk categorization by PAaM at the age of 40 may no longer be relevant at 50 or 60 as liver disease progresses.”
Although the tool is “exciting,” Reau suggested that it is also “premature” until appropriate reclassification intervals are understood.
She also noted that some patients still develop HCC despite being considered low risk, including cases of HCC that develop in non-cirrhotic HCV infection or MASLD.
Beyond the above clinical considerations, Dr. Reau pointed out several barriers to implementing PAaM in routine practice, starting with the under-recognition of cirrhosis. Even if patients are identified, ensuring both clinicians and patients adhere to screening recommendations remains a challenge.
Finally, financial considerations may pose obstacles.
“If some payers cover the tool and others do not, it will be very difficult to implement,” Dr. Reau concluded.
Reau reported no conflicts of interest.
Nancy S. Reau, MD, AGAF, of RUSH University in Chicago, highlighted both the promise and challenges of the PAaM score for HCC risk stratification, emphasizing that current liver cancer screening strategies remain inadequate, with only about 25% of patients receiving guideline-recommended surveillance.
“An easy-to-apply cost effective tool could significantly improve screening strategies, which should lead to earlier identification of liver cancer—at a time when curative treatment options are available,” Reau said.
PAaM, however, may be impractical for routine use.
“A tool that classifies people into 3 different screening strategies and requires longitudinal applications and re-classification could add complexity,” she explained, predicting that “clinicians aren’t going to use it correctly.
Reau was particularly concerned about the need for repeated assessments over time.
“People change,” she said. “A low-risk categorization by PAaM at the age of 40 may no longer be relevant at 50 or 60 as liver disease progresses.”
Although the tool is “exciting,” Reau suggested that it is also “premature” until appropriate reclassification intervals are understood.
She also noted that some patients still develop HCC despite being considered low risk, including cases of HCC that develop in non-cirrhotic HCV infection or MASLD.
Beyond the above clinical considerations, Dr. Reau pointed out several barriers to implementing PAaM in routine practice, starting with the under-recognition of cirrhosis. Even if patients are identified, ensuring both clinicians and patients adhere to screening recommendations remains a challenge.
Finally, financial considerations may pose obstacles.
“If some payers cover the tool and others do not, it will be very difficult to implement,” Dr. Reau concluded.
Reau reported no conflicts of interest.
, based to a recent phase 3 biomarker validation study.
The Prognostic Liver Secretome Signature with Alpha-Fetoprotein plus Age, Male Sex, Albumin-Bilirubin, and Platelets (PAaM) score integrates both molecular and clinical variables to effectively classify cirrhosis patients by their risk of developing HCC, potentially sparing low-risk patients from unnecessary surveillance, lead author Naoto Fujiwara, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, and colleagues reported.
“Hepatocellular carcinoma risk stratification is an urgent unmet need for cost-effective screening and early detection in patients with cirrhosis,” the investigators wrote in Gastroenterology. “This study represents the largest and first phase 3 biomarker validation study that establishes an integrative molecular/clinical score, PAaM, for HCC risk stratification.”
The PAaM score combines an 8-protein prognostic liver secretome signature with traditional clinical variables, including alpha-fetoprotein (AFP) levels, age, sex, albumin-bilirubin levels, and platelet counts. The score stratifies patients into high-, intermediate-, and low-risk categories.
The PAaM score was validated using 2 independent prospective cohorts in the United States: the statewide Texas Hepatocellular Carcinoma Consortium (THCCC) and the nationwide Hepatocellular Carcinoma Early Detection Strategy (HEDS). Across both cohorts, 3,484 patients with cirrhosis were followed over time to assess the development of HCC.
In the Texas cohort, comprising 2,156 patients with cirrhosis, PAaM classified 19% of patients as high risk, 42% as intermediate risk, and 39% as low risk. The annual incidence of HCC was significantly different across these groups, with high-risk patients experiencing a 5.3% incidence rate, versus 2.7% for intermediate-risk patients and 0.6% for low-risk patients (P less than .001). Compared with those in the low-risk group, high-risk patients had sub-distribution hazard ratio (sHR) of 7.51 for developing HCC, while intermediate-risk patients had an sHR of 4.20.
In the nationwide HEDS cohort, which included 1,328 patients, PAaM similarly stratified 15% of participants as high risk, 41% as intermediate risk, and 44% as low risk. Annual HCC incidence rates were 6.2%, 1.8%, and 0.8% for high-, intermediate-, and low-risk patients, respectively (P less than .001). Among these patients, sub-distribution hazard ratios for HCC were 6.54 for high-risk patients and 1.77 for intermediate-risk patients, again underscoring the tool’s potential to identify individuals at elevated risk of developing HCC.
The PAaM score outperformed existing models like the aMAP score and the PLSec-AFP molecular marker alone, with consistent superiority across a diverse range of cirrhosis etiologies, including metabolic dysfunction–associated steatotic liver disease (MASLD), alcohol-associated liver disease (ALD), and cured hepatitis C virus (HCV) infection.
Based on these findings, high-risk patients might benefit from more intensive screening strategies, Fujiwara and colleagues suggested, while intermediate-risk patients could continue with semi-annual ultrasound-based screening. Of note, low-risk patients—comprising about 40% of the study population—could potentially avoid frequent screenings, thus reducing healthcare costs and minimizing unnecessary interventions.
“This represents a significant step toward the clinical translation of an individual risk-based HCC screening strategy to improve early HCC detection and reduce HCC mortality,” the investigators concluded.This study was supported by various the National Cancer Institute, Veterans Affairs, the Japan Society for the Promotion of Science, and others. The investigators disclosed additional relationships with Boston Scientific, Sirtex, Bayer, and others.
, based to a recent phase 3 biomarker validation study.
The Prognostic Liver Secretome Signature with Alpha-Fetoprotein plus Age, Male Sex, Albumin-Bilirubin, and Platelets (PAaM) score integrates both molecular and clinical variables to effectively classify cirrhosis patients by their risk of developing HCC, potentially sparing low-risk patients from unnecessary surveillance, lead author Naoto Fujiwara, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, and colleagues reported.
“Hepatocellular carcinoma risk stratification is an urgent unmet need for cost-effective screening and early detection in patients with cirrhosis,” the investigators wrote in Gastroenterology. “This study represents the largest and first phase 3 biomarker validation study that establishes an integrative molecular/clinical score, PAaM, for HCC risk stratification.”
The PAaM score combines an 8-protein prognostic liver secretome signature with traditional clinical variables, including alpha-fetoprotein (AFP) levels, age, sex, albumin-bilirubin levels, and platelet counts. The score stratifies patients into high-, intermediate-, and low-risk categories.
The PAaM score was validated using 2 independent prospective cohorts in the United States: the statewide Texas Hepatocellular Carcinoma Consortium (THCCC) and the nationwide Hepatocellular Carcinoma Early Detection Strategy (HEDS). Across both cohorts, 3,484 patients with cirrhosis were followed over time to assess the development of HCC.
In the Texas cohort, comprising 2,156 patients with cirrhosis, PAaM classified 19% of patients as high risk, 42% as intermediate risk, and 39% as low risk. The annual incidence of HCC was significantly different across these groups, with high-risk patients experiencing a 5.3% incidence rate, versus 2.7% for intermediate-risk patients and 0.6% for low-risk patients (P less than .001). Compared with those in the low-risk group, high-risk patients had sub-distribution hazard ratio (sHR) of 7.51 for developing HCC, while intermediate-risk patients had an sHR of 4.20.
In the nationwide HEDS cohort, which included 1,328 patients, PAaM similarly stratified 15% of participants as high risk, 41% as intermediate risk, and 44% as low risk. Annual HCC incidence rates were 6.2%, 1.8%, and 0.8% for high-, intermediate-, and low-risk patients, respectively (P less than .001). Among these patients, sub-distribution hazard ratios for HCC were 6.54 for high-risk patients and 1.77 for intermediate-risk patients, again underscoring the tool’s potential to identify individuals at elevated risk of developing HCC.
The PAaM score outperformed existing models like the aMAP score and the PLSec-AFP molecular marker alone, with consistent superiority across a diverse range of cirrhosis etiologies, including metabolic dysfunction–associated steatotic liver disease (MASLD), alcohol-associated liver disease (ALD), and cured hepatitis C virus (HCV) infection.
Based on these findings, high-risk patients might benefit from more intensive screening strategies, Fujiwara and colleagues suggested, while intermediate-risk patients could continue with semi-annual ultrasound-based screening. Of note, low-risk patients—comprising about 40% of the study population—could potentially avoid frequent screenings, thus reducing healthcare costs and minimizing unnecessary interventions.
“This represents a significant step toward the clinical translation of an individual risk-based HCC screening strategy to improve early HCC detection and reduce HCC mortality,” the investigators concluded.This study was supported by various the National Cancer Institute, Veterans Affairs, the Japan Society for the Promotion of Science, and others. The investigators disclosed additional relationships with Boston Scientific, Sirtex, Bayer, and others.
FROM GASTROENTEROLOGY