User login
Less Invasive Sponge Test Stratifies Risk in Patients With Barrett’s Esophagus
The biomarker risk panel collected by the panesophageal Cytosponge-on-a-string in more than 900 UK patients helped identify those at highest risk for dysplasia or cancer and needing endoscopy. It was found safe for following low-risk patients who did not need endoscopy.
Endoscopic surveillance is the clinical standard for BE, but its effectiveness is inconsistent, wrote Rebecca C. Fitzgerald, MD, AGAF, professor in the Early Cancer Institute at the University of Cambridge in Cambridge, England, and colleagues in The Lancet.
“It is often performed by nonspecialists, and recent trials show that around 10% of cases of dysplasia and cancer are missed, which means some patients re-present within a year of their surveillance procedure with a symptomatic cancer that should have been diagnosed earlier,” Fitzgerald told GI & Hepatology News.
Moreover, repeated endoscopy monitoring is stressful. “A simple nonendoscopic capsule sponge test done nearer to home is less scary and could be less operator-dependent. By reducing the burden of endoscopy in patients at very low risk we can focus more on the patients at higher risk,” she said.
In 2022, her research group had reported that the capsule sponge test, coupled with a centralized lab test for p53 and atypia, can risk-stratify patients into low-, moderate-, and high-risk groups. “In the current study, we wanted to check this risk stratification capsule sponge test in the real world. Our main aim was to see if we could conform the 2022 results with the hypothesis that the low-risk patients — more than 50% of patients in surveillance — would have a risk of high-grade dysplasia or cancer that was sufficiently low — that is, less than from 3% — and could therefore have follow-up with the capsule sponge without requiring endoscopy.”
The investigators hypothesized that the 15% at high risk would have a significant chance of dysplasia warranting endoscopy in a specialist center.
“Our results showed that in the low-risk group the risk of high-grade dysplasia or cancer was 0.4%, suggesting these patients could be offered follow-up with the capsule sponge test,” Fitzgerald said.
The high-risk group with a double biomarker positive (p53 and atypia) had an 85% risk for dysplasia or cancer. “We call this a tier 1 or ultra-high risk, and this suggests these cases merit a specialist endoscopy in a center that could treat the dysplasia/cancer,” she said.
Study Details
Adult participants (n = 910) were recruited from August 2020 to December 2024 in two multicenter, prospective, pragmatic implementation studies from 13 hospitals. Patients with nondysplastic BE on last endoscopy had a capsule sponge test.
Patient risk was assigned as low (clinical and capsule sponge biomarkers negative), moderate (negative for capsule sponge biomarkers, positive clinical biomarkers: age, sex, and segment length), or high risk (p53 abnormality, glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group.
In the cohort, 138 (15%) were classified as having high risk, 283 (31%) had moderate risk, and 489 (54%) had low risk.
The positive predictive value for any dysplasia or worse in the high-risk group was 37.7% (95% CI, 29.7-46.4). Patients with both atypia and aberrant p53 had the highest risk for high-grade dysplasia or cancer with a relative risk of 135.8 (95% CI, 32.7-564.0) vs the low-risk group.
The prevalence of high-grade dysplasia or cancer in the low-risk group was, as mentioned, just 0.4% (95% CI, 0.1-1.6), while the negative predictive value for any dysplasia or cancer was 97.8% (95% CI, 95.9-98.8). Applying a machine learning algorithm reduced the proportion needing p53 pathology review to 32% without missing any positive cases.
Offering a US perspective on the study, Nicholas J. Shaheen, MD, MPH, AGAF, professor of medicine and director of the NC Translational & Clinical Sciences Institute at the University of North Carolina School of Medicine in Chapel Hill, called the findings “very provocative.”
“We have known for some time that nonendoscopic techniques could be used to screen for Barrett’s esophagus and esophageal cancer, allowing us to screen larger groups of patients in a more cost-effective manner compared to traditional upper endoscopy,” he told GI & Hepatology News. “This study suggests that, in addition to case-finding for Barrett’s [esophagus], a nonendoscopic sponge-based technique can also help us stratify risk, finding cases that either already harbor cancer or are at high risk to do so.”
Shaheen said these cases deserve immediate attention since they are most likely to benefit from timely endoscopic intervention. “The study also suggests that a nonendoscopic result could someday be used to decide subsequent follow-up, with low-risk patients undergoing further nonendoscopic surveillance, while higher-risk patients would move on to endoscopy. Such a paradigm could unburden our endoscopy units from low-risk patients unlikely to benefit from endoscopy as well as increase the numbers of patients who are able to be screened.”
Fitzgerald added, “The GI community is realizing that we need a better approach to managing patients with Barrett’s [esophagus]. In the UK this evidence is being considered by our guideline committee, and it would influence the upcoming guidelines in 2025 with a requirement to continue to audit the results. Outside of the UK we hope this will pave the way for nonendoscopic approaches to Barrett’s [esophagus] surveillance.”
One ongoing goal is to optimize the biomarkers, Fitzgerald said. “For patients with longer segments we would like to add additional genomic biomarkers to refine the risk predictions,” she said. “We need a more operator-independent, consistent method for monitoring Barrett’s [esophagus]. This large real-world study is highly encouraging for a more personalized and patient-friendly approach to Barrett’s [esophagus] surveillance.”
This study was funded by Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance. Cytosponge technology is licensed by the Medical Research Council to Medtronic. Fitzgerald declared holding patents related to this test. Fitzgerald reported being a shareholder in Cyted Health.
Shaheen reported receiving research funding from Lucid Diagnostics and Cyted Health, both of which are manufacturers of nonendoscopic screening devices for BE.
A version of this article appeared on Medscape.com.
The biomarker risk panel collected by the panesophageal Cytosponge-on-a-string in more than 900 UK patients helped identify those at highest risk for dysplasia or cancer and needing endoscopy. It was found safe for following low-risk patients who did not need endoscopy.
Endoscopic surveillance is the clinical standard for BE, but its effectiveness is inconsistent, wrote Rebecca C. Fitzgerald, MD, AGAF, professor in the Early Cancer Institute at the University of Cambridge in Cambridge, England, and colleagues in The Lancet.
“It is often performed by nonspecialists, and recent trials show that around 10% of cases of dysplasia and cancer are missed, which means some patients re-present within a year of their surveillance procedure with a symptomatic cancer that should have been diagnosed earlier,” Fitzgerald told GI & Hepatology News.
Moreover, repeated endoscopy monitoring is stressful. “A simple nonendoscopic capsule sponge test done nearer to home is less scary and could be less operator-dependent. By reducing the burden of endoscopy in patients at very low risk we can focus more on the patients at higher risk,” she said.
In 2022, her research group had reported that the capsule sponge test, coupled with a centralized lab test for p53 and atypia, can risk-stratify patients into low-, moderate-, and high-risk groups. “In the current study, we wanted to check this risk stratification capsule sponge test in the real world. Our main aim was to see if we could conform the 2022 results with the hypothesis that the low-risk patients — more than 50% of patients in surveillance — would have a risk of high-grade dysplasia or cancer that was sufficiently low — that is, less than from 3% — and could therefore have follow-up with the capsule sponge without requiring endoscopy.”
The investigators hypothesized that the 15% at high risk would have a significant chance of dysplasia warranting endoscopy in a specialist center.
“Our results showed that in the low-risk group the risk of high-grade dysplasia or cancer was 0.4%, suggesting these patients could be offered follow-up with the capsule sponge test,” Fitzgerald said.
The high-risk group with a double biomarker positive (p53 and atypia) had an 85% risk for dysplasia or cancer. “We call this a tier 1 or ultra-high risk, and this suggests these cases merit a specialist endoscopy in a center that could treat the dysplasia/cancer,” she said.
Study Details
Adult participants (n = 910) were recruited from August 2020 to December 2024 in two multicenter, prospective, pragmatic implementation studies from 13 hospitals. Patients with nondysplastic BE on last endoscopy had a capsule sponge test.
Patient risk was assigned as low (clinical and capsule sponge biomarkers negative), moderate (negative for capsule sponge biomarkers, positive clinical biomarkers: age, sex, and segment length), or high risk (p53 abnormality, glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group.
In the cohort, 138 (15%) were classified as having high risk, 283 (31%) had moderate risk, and 489 (54%) had low risk.
The positive predictive value for any dysplasia or worse in the high-risk group was 37.7% (95% CI, 29.7-46.4). Patients with both atypia and aberrant p53 had the highest risk for high-grade dysplasia or cancer with a relative risk of 135.8 (95% CI, 32.7-564.0) vs the low-risk group.
The prevalence of high-grade dysplasia or cancer in the low-risk group was, as mentioned, just 0.4% (95% CI, 0.1-1.6), while the negative predictive value for any dysplasia or cancer was 97.8% (95% CI, 95.9-98.8). Applying a machine learning algorithm reduced the proportion needing p53 pathology review to 32% without missing any positive cases.
Offering a US perspective on the study, Nicholas J. Shaheen, MD, MPH, AGAF, professor of medicine and director of the NC Translational & Clinical Sciences Institute at the University of North Carolina School of Medicine in Chapel Hill, called the findings “very provocative.”
“We have known for some time that nonendoscopic techniques could be used to screen for Barrett’s esophagus and esophageal cancer, allowing us to screen larger groups of patients in a more cost-effective manner compared to traditional upper endoscopy,” he told GI & Hepatology News. “This study suggests that, in addition to case-finding for Barrett’s [esophagus], a nonendoscopic sponge-based technique can also help us stratify risk, finding cases that either already harbor cancer or are at high risk to do so.”
Shaheen said these cases deserve immediate attention since they are most likely to benefit from timely endoscopic intervention. “The study also suggests that a nonendoscopic result could someday be used to decide subsequent follow-up, with low-risk patients undergoing further nonendoscopic surveillance, while higher-risk patients would move on to endoscopy. Such a paradigm could unburden our endoscopy units from low-risk patients unlikely to benefit from endoscopy as well as increase the numbers of patients who are able to be screened.”
Fitzgerald added, “The GI community is realizing that we need a better approach to managing patients with Barrett’s [esophagus]. In the UK this evidence is being considered by our guideline committee, and it would influence the upcoming guidelines in 2025 with a requirement to continue to audit the results. Outside of the UK we hope this will pave the way for nonendoscopic approaches to Barrett’s [esophagus] surveillance.”
One ongoing goal is to optimize the biomarkers, Fitzgerald said. “For patients with longer segments we would like to add additional genomic biomarkers to refine the risk predictions,” she said. “We need a more operator-independent, consistent method for monitoring Barrett’s [esophagus]. This large real-world study is highly encouraging for a more personalized and patient-friendly approach to Barrett’s [esophagus] surveillance.”
This study was funded by Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance. Cytosponge technology is licensed by the Medical Research Council to Medtronic. Fitzgerald declared holding patents related to this test. Fitzgerald reported being a shareholder in Cyted Health.
Shaheen reported receiving research funding from Lucid Diagnostics and Cyted Health, both of which are manufacturers of nonendoscopic screening devices for BE.
A version of this article appeared on Medscape.com.
The biomarker risk panel collected by the panesophageal Cytosponge-on-a-string in more than 900 UK patients helped identify those at highest risk for dysplasia or cancer and needing endoscopy. It was found safe for following low-risk patients who did not need endoscopy.
Endoscopic surveillance is the clinical standard for BE, but its effectiveness is inconsistent, wrote Rebecca C. Fitzgerald, MD, AGAF, professor in the Early Cancer Institute at the University of Cambridge in Cambridge, England, and colleagues in The Lancet.
“It is often performed by nonspecialists, and recent trials show that around 10% of cases of dysplasia and cancer are missed, which means some patients re-present within a year of their surveillance procedure with a symptomatic cancer that should have been diagnosed earlier,” Fitzgerald told GI & Hepatology News.
Moreover, repeated endoscopy monitoring is stressful. “A simple nonendoscopic capsule sponge test done nearer to home is less scary and could be less operator-dependent. By reducing the burden of endoscopy in patients at very low risk we can focus more on the patients at higher risk,” she said.
In 2022, her research group had reported that the capsule sponge test, coupled with a centralized lab test for p53 and atypia, can risk-stratify patients into low-, moderate-, and high-risk groups. “In the current study, we wanted to check this risk stratification capsule sponge test in the real world. Our main aim was to see if we could conform the 2022 results with the hypothesis that the low-risk patients — more than 50% of patients in surveillance — would have a risk of high-grade dysplasia or cancer that was sufficiently low — that is, less than from 3% — and could therefore have follow-up with the capsule sponge without requiring endoscopy.”
The investigators hypothesized that the 15% at high risk would have a significant chance of dysplasia warranting endoscopy in a specialist center.
“Our results showed that in the low-risk group the risk of high-grade dysplasia or cancer was 0.4%, suggesting these patients could be offered follow-up with the capsule sponge test,” Fitzgerald said.
The high-risk group with a double biomarker positive (p53 and atypia) had an 85% risk for dysplasia or cancer. “We call this a tier 1 or ultra-high risk, and this suggests these cases merit a specialist endoscopy in a center that could treat the dysplasia/cancer,” she said.
Study Details
Adult participants (n = 910) were recruited from August 2020 to December 2024 in two multicenter, prospective, pragmatic implementation studies from 13 hospitals. Patients with nondysplastic BE on last endoscopy had a capsule sponge test.
Patient risk was assigned as low (clinical and capsule sponge biomarkers negative), moderate (negative for capsule sponge biomarkers, positive clinical biomarkers: age, sex, and segment length), or high risk (p53 abnormality, glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group.
In the cohort, 138 (15%) were classified as having high risk, 283 (31%) had moderate risk, and 489 (54%) had low risk.
The positive predictive value for any dysplasia or worse in the high-risk group was 37.7% (95% CI, 29.7-46.4). Patients with both atypia and aberrant p53 had the highest risk for high-grade dysplasia or cancer with a relative risk of 135.8 (95% CI, 32.7-564.0) vs the low-risk group.
The prevalence of high-grade dysplasia or cancer in the low-risk group was, as mentioned, just 0.4% (95% CI, 0.1-1.6), while the negative predictive value for any dysplasia or cancer was 97.8% (95% CI, 95.9-98.8). Applying a machine learning algorithm reduced the proportion needing p53 pathology review to 32% without missing any positive cases.
Offering a US perspective on the study, Nicholas J. Shaheen, MD, MPH, AGAF, professor of medicine and director of the NC Translational & Clinical Sciences Institute at the University of North Carolina School of Medicine in Chapel Hill, called the findings “very provocative.”
“We have known for some time that nonendoscopic techniques could be used to screen for Barrett’s esophagus and esophageal cancer, allowing us to screen larger groups of patients in a more cost-effective manner compared to traditional upper endoscopy,” he told GI & Hepatology News. “This study suggests that, in addition to case-finding for Barrett’s [esophagus], a nonendoscopic sponge-based technique can also help us stratify risk, finding cases that either already harbor cancer or are at high risk to do so.”
Shaheen said these cases deserve immediate attention since they are most likely to benefit from timely endoscopic intervention. “The study also suggests that a nonendoscopic result could someday be used to decide subsequent follow-up, with low-risk patients undergoing further nonendoscopic surveillance, while higher-risk patients would move on to endoscopy. Such a paradigm could unburden our endoscopy units from low-risk patients unlikely to benefit from endoscopy as well as increase the numbers of patients who are able to be screened.”
Fitzgerald added, “The GI community is realizing that we need a better approach to managing patients with Barrett’s [esophagus]. In the UK this evidence is being considered by our guideline committee, and it would influence the upcoming guidelines in 2025 with a requirement to continue to audit the results. Outside of the UK we hope this will pave the way for nonendoscopic approaches to Barrett’s [esophagus] surveillance.”
One ongoing goal is to optimize the biomarkers, Fitzgerald said. “For patients with longer segments we would like to add additional genomic biomarkers to refine the risk predictions,” she said. “We need a more operator-independent, consistent method for monitoring Barrett’s [esophagus]. This large real-world study is highly encouraging for a more personalized and patient-friendly approach to Barrett’s [esophagus] surveillance.”
This study was funded by Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance. Cytosponge technology is licensed by the Medical Research Council to Medtronic. Fitzgerald declared holding patents related to this test. Fitzgerald reported being a shareholder in Cyted Health.
Shaheen reported receiving research funding from Lucid Diagnostics and Cyted Health, both of which are manufacturers of nonendoscopic screening devices for BE.
A version of this article appeared on Medscape.com.
More Evidence Supports ‘Individualized Approach’ to Pre-Endoscopy GLP-1 RAs
in The American Journal of Gastroenterology. Moreover, most instances occurred in patients using the drugs for type 2 diabetes (T2D) rather than for weight loss alone.
The findings suggest adopting an individualized approach rather than universal preoperative withholding of GLP-1 RAs before endoscopy, concluded Jennifer Phan, MD, medical director of the Hoag Advanced Endoscopy Center in Newport Beach, California, and colleagues. These agents are associated with slowed gastric emptying, possibly raising the risk for pulmonary aspiration. The study identified comorbid uncontrolled T2D as a risk factor for retained gastric contents.
Recommendations from gastroenterological societies and the American Society of Anesthesiologists (ASA) differ regarding pre-endoscopic holding of these ubiquitous agents used for obesity and T2D. “Many patients undergo routine endoscopic procedures, and there was concern from the anesthesia safety perspective for retained gastric contents,” Phan told GI & Hepatology News. “At first these events were seen in a handful of cases; however, out of precaution this resulted in a statement from the ASA recommending that patients hold their GLP-1 medications for at least 1 week prior to a routine endoscopic procedure.”
That guidance resulted in protocol changes within endoscopy units, cancelled procedures, and potential delays in patient care. “We wanted to study whether this concern was clinically valid and to help identify which subgroup of patients are at highest risk in order to best inform anesthesia and endoscopy practices,” Phan added.
The ASA updated its guidance in 2023.
The current study aligns with other research showing that rates of clinically relevant retained gastric contents are < 10%, Phan said. For instance, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures. AGA guidance suggests an individual approach for each patient on a GLP-1 RA rather than a blanket statement on how to manage all patients taking the medications.
“Our initial hypothesis was that the rates of clinically relevant retained gastric contents in patients on GLP-1 RA medications would be low,” Phan noted. “This was born out of anecdotal experience of the limited number of aborted procedures we experienced before the ASA statement.”
Her group also hypothesized that the indication for which the GLP-1 RA was prescribed would be important, with patients taking GLP-1 RA medications for diabetes potentially having a higher likelihood of retained contents given the concomitant propensity for delayed gastric motility related to uncontrolled hyperglycemia.
The Study
The investigators identified 815 patients on confirmed GLP-1 RA medications of various types receiving endoscopy from 2021 to 2023 at four centers. Demographics, prescribing practices, and procedure outcomes were captured. GLP-1 RA management of preoperative holding was retroactively classified per ASA guidance.
Of the 815 patients (mean age, 67.7 years; 57.7% women; 53.9% White individuals), 70 (8.7%) exhibited retained gastric contents on endoscopy. Of these 65 (93%) had T2D with a median A1c of 6.5%. Among those with retained contents, most had a minimal (10, 14.3%) or moderate (31, 44.3%) amount of food retained, although 29 (41.4%) had a large quantity. Only one patient required unplanned intubation because of a large quantity of residual content, and none had aspiration events.
In multivariate analysis, the odds ratio of retention in those with diabetes was 4.1. “Given the predominance of diabetes in those with retained gastric contents, we highlight the potential to risk-stratify patients who require further preprocedural consideration,” the authors wrote.
Those with GLP-1 RA held per ASA guidance (406, 49.8%) were less likely to have retained contents (4.4% vs 12.7%; P < .001), but no significant differences for intubation (0% vs 2%; P = .53) or aborting procedure rates (28% vs 18%; P = .40) due to gastric retention were observed.
On multivariable analysis, the likelihood of food retention increased by 36% (95% CI, 1.15-1.60) for every 1% increase in glycosylated hemoglobin after adjusting for GLP-1 RA type and preoperative medication hold.
“Our study can help to differentiate which patients can be at largest risk for retained gastric contents,” Phan said, noting the impact of increasing percentages of A1C. “There’s a 36% increased likelihood of food retention in patients on GLP-1 medications, so a blanket policy to hold GLP-1s in patients who are nondiabetic and taking the medication for obesity may not be the best approach. But if patients have uncontrolled hyperglycemia, then an approach of caution is clinically valid.” In that context, holding the GLP-1 RA injection or lengthening the preoperative clear-liquid diet policy should be considered.
She noted that the study results are generalizable because the study was conducted across multiple types of hospital systems, both university and county, and included all types of GLP-1 RA.
Offering an anesthesiologist’s perspective on the study, Paul Potnuru, MD, an assistant professor in the Department of Anesthesiology, Critical Care, and Pain Medicine at UTHealth Houston and not involved in the study, called the findings “somewhat reassuring” but said the risk for aspiration was still a consideration.
A recent review, however, reported that the risk for GLP-1 RA-associated pulmonary aspiration was low.
Potnuru acknowledged that the original ASA guidance on preoperative GLP-1 RA cessation led to some confusion. “There were not a lot of data on the issue, but some studies found that even with stopping GLP-1s 2 weeks preoperatively some patients still retained gastric content,” he told GI & Hepatology News.
A study at his center recently reported that 56% of GLP-1 RA users had increased pre-anesthesia residual gastric content compared with 19% of nonusers.
From the anesthesiologist’s clinical vantage point, the margin of safety is an issue even if aspiration risk is low. “If there’s a 1 in 1000 chance or even a 1 in 3000 chance, that can be considered too high,” Potnuru said.
He further noted that the current study included only 815 patients, not nearly enough for definitive data. In addition, a retrospective study based on medical records can’t really capture all the real-world procedural changes made in the operating room. “It’s common for anesthesiologists not to document all cases of intubation, for example,” he said.
While the ideal is a completely empty stomach, he agreed that a practical alternative to stopping GLP-1 RA therapy, especially that prescribed for diabetes, would be a 24-hour liquid diet, which would clear the stomach quickly. “If you stop these drugs in patients taking them for diabetes, you get a worsening of their glycemic control,” he said.
He noted that patients have different risk tolerances, with some willing to go ahead even if ultrasound shows gastric retention, while some opt to cancel.
Prospective studies are needed, Potnuru added, “because you find more if you know what you’re looking for.” His center is starting a clinical trial in 150 patients to assess the impact of a 24-hour, liquids-only diet on gastric retention.
According to Phan, other research is following GLP-1 RA users undergoing colonoscopy. “Future studies can look at the added value of point-of-care abdominal ultrasound to see if it increases precision preoperative management in these patients on GLP-1 medications.”
Other groups are examining the safety of these agents in the general context of sedation. “It’s worth noting that the studies are being done on currently available medications and may not apply to future medications such as triple agonists or anti-amylins that may come on the market in the near future,” Phan said.
This study received no financial support. Neither the study authors nor Potnuru had any conflicts of interest.
A version of this article appeared on Medscape.com.
in The American Journal of Gastroenterology. Moreover, most instances occurred in patients using the drugs for type 2 diabetes (T2D) rather than for weight loss alone.
The findings suggest adopting an individualized approach rather than universal preoperative withholding of GLP-1 RAs before endoscopy, concluded Jennifer Phan, MD, medical director of the Hoag Advanced Endoscopy Center in Newport Beach, California, and colleagues. These agents are associated with slowed gastric emptying, possibly raising the risk for pulmonary aspiration. The study identified comorbid uncontrolled T2D as a risk factor for retained gastric contents.
Recommendations from gastroenterological societies and the American Society of Anesthesiologists (ASA) differ regarding pre-endoscopic holding of these ubiquitous agents used for obesity and T2D. “Many patients undergo routine endoscopic procedures, and there was concern from the anesthesia safety perspective for retained gastric contents,” Phan told GI & Hepatology News. “At first these events were seen in a handful of cases; however, out of precaution this resulted in a statement from the ASA recommending that patients hold their GLP-1 medications for at least 1 week prior to a routine endoscopic procedure.”
That guidance resulted in protocol changes within endoscopy units, cancelled procedures, and potential delays in patient care. “We wanted to study whether this concern was clinically valid and to help identify which subgroup of patients are at highest risk in order to best inform anesthesia and endoscopy practices,” Phan added.
The ASA updated its guidance in 2023.
The current study aligns with other research showing that rates of clinically relevant retained gastric contents are < 10%, Phan said. For instance, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures. AGA guidance suggests an individual approach for each patient on a GLP-1 RA rather than a blanket statement on how to manage all patients taking the medications.
“Our initial hypothesis was that the rates of clinically relevant retained gastric contents in patients on GLP-1 RA medications would be low,” Phan noted. “This was born out of anecdotal experience of the limited number of aborted procedures we experienced before the ASA statement.”
Her group also hypothesized that the indication for which the GLP-1 RA was prescribed would be important, with patients taking GLP-1 RA medications for diabetes potentially having a higher likelihood of retained contents given the concomitant propensity for delayed gastric motility related to uncontrolled hyperglycemia.
The Study
The investigators identified 815 patients on confirmed GLP-1 RA medications of various types receiving endoscopy from 2021 to 2023 at four centers. Demographics, prescribing practices, and procedure outcomes were captured. GLP-1 RA management of preoperative holding was retroactively classified per ASA guidance.
Of the 815 patients (mean age, 67.7 years; 57.7% women; 53.9% White individuals), 70 (8.7%) exhibited retained gastric contents on endoscopy. Of these 65 (93%) had T2D with a median A1c of 6.5%. Among those with retained contents, most had a minimal (10, 14.3%) or moderate (31, 44.3%) amount of food retained, although 29 (41.4%) had a large quantity. Only one patient required unplanned intubation because of a large quantity of residual content, and none had aspiration events.
In multivariate analysis, the odds ratio of retention in those with diabetes was 4.1. “Given the predominance of diabetes in those with retained gastric contents, we highlight the potential to risk-stratify patients who require further preprocedural consideration,” the authors wrote.
Those with GLP-1 RA held per ASA guidance (406, 49.8%) were less likely to have retained contents (4.4% vs 12.7%; P < .001), but no significant differences for intubation (0% vs 2%; P = .53) or aborting procedure rates (28% vs 18%; P = .40) due to gastric retention were observed.
On multivariable analysis, the likelihood of food retention increased by 36% (95% CI, 1.15-1.60) for every 1% increase in glycosylated hemoglobin after adjusting for GLP-1 RA type and preoperative medication hold.
“Our study can help to differentiate which patients can be at largest risk for retained gastric contents,” Phan said, noting the impact of increasing percentages of A1C. “There’s a 36% increased likelihood of food retention in patients on GLP-1 medications, so a blanket policy to hold GLP-1s in patients who are nondiabetic and taking the medication for obesity may not be the best approach. But if patients have uncontrolled hyperglycemia, then an approach of caution is clinically valid.” In that context, holding the GLP-1 RA injection or lengthening the preoperative clear-liquid diet policy should be considered.
She noted that the study results are generalizable because the study was conducted across multiple types of hospital systems, both university and county, and included all types of GLP-1 RA.
Offering an anesthesiologist’s perspective on the study, Paul Potnuru, MD, an assistant professor in the Department of Anesthesiology, Critical Care, and Pain Medicine at UTHealth Houston and not involved in the study, called the findings “somewhat reassuring” but said the risk for aspiration was still a consideration.
A recent review, however, reported that the risk for GLP-1 RA-associated pulmonary aspiration was low.
Potnuru acknowledged that the original ASA guidance on preoperative GLP-1 RA cessation led to some confusion. “There were not a lot of data on the issue, but some studies found that even with stopping GLP-1s 2 weeks preoperatively some patients still retained gastric content,” he told GI & Hepatology News.
A study at his center recently reported that 56% of GLP-1 RA users had increased pre-anesthesia residual gastric content compared with 19% of nonusers.
From the anesthesiologist’s clinical vantage point, the margin of safety is an issue even if aspiration risk is low. “If there’s a 1 in 1000 chance or even a 1 in 3000 chance, that can be considered too high,” Potnuru said.
He further noted that the current study included only 815 patients, not nearly enough for definitive data. In addition, a retrospective study based on medical records can’t really capture all the real-world procedural changes made in the operating room. “It’s common for anesthesiologists not to document all cases of intubation, for example,” he said.
While the ideal is a completely empty stomach, he agreed that a practical alternative to stopping GLP-1 RA therapy, especially that prescribed for diabetes, would be a 24-hour liquid diet, which would clear the stomach quickly. “If you stop these drugs in patients taking them for diabetes, you get a worsening of their glycemic control,” he said.
He noted that patients have different risk tolerances, with some willing to go ahead even if ultrasound shows gastric retention, while some opt to cancel.
Prospective studies are needed, Potnuru added, “because you find more if you know what you’re looking for.” His center is starting a clinical trial in 150 patients to assess the impact of a 24-hour, liquids-only diet on gastric retention.
According to Phan, other research is following GLP-1 RA users undergoing colonoscopy. “Future studies can look at the added value of point-of-care abdominal ultrasound to see if it increases precision preoperative management in these patients on GLP-1 medications.”
Other groups are examining the safety of these agents in the general context of sedation. “It’s worth noting that the studies are being done on currently available medications and may not apply to future medications such as triple agonists or anti-amylins that may come on the market in the near future,” Phan said.
This study received no financial support. Neither the study authors nor Potnuru had any conflicts of interest.
A version of this article appeared on Medscape.com.
in The American Journal of Gastroenterology. Moreover, most instances occurred in patients using the drugs for type 2 diabetes (T2D) rather than for weight loss alone.
The findings suggest adopting an individualized approach rather than universal preoperative withholding of GLP-1 RAs before endoscopy, concluded Jennifer Phan, MD, medical director of the Hoag Advanced Endoscopy Center in Newport Beach, California, and colleagues. These agents are associated with slowed gastric emptying, possibly raising the risk for pulmonary aspiration. The study identified comorbid uncontrolled T2D as a risk factor for retained gastric contents.
Recommendations from gastroenterological societies and the American Society of Anesthesiologists (ASA) differ regarding pre-endoscopic holding of these ubiquitous agents used for obesity and T2D. “Many patients undergo routine endoscopic procedures, and there was concern from the anesthesia safety perspective for retained gastric contents,” Phan told GI & Hepatology News. “At first these events were seen in a handful of cases; however, out of precaution this resulted in a statement from the ASA recommending that patients hold their GLP-1 medications for at least 1 week prior to a routine endoscopic procedure.”
That guidance resulted in protocol changes within endoscopy units, cancelled procedures, and potential delays in patient care. “We wanted to study whether this concern was clinically valid and to help identify which subgroup of patients are at highest risk in order to best inform anesthesia and endoscopy practices,” Phan added.
The ASA updated its guidance in 2023.
The current study aligns with other research showing that rates of clinically relevant retained gastric contents are < 10%, Phan said. For instance, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures. AGA guidance suggests an individual approach for each patient on a GLP-1 RA rather than a blanket statement on how to manage all patients taking the medications.
“Our initial hypothesis was that the rates of clinically relevant retained gastric contents in patients on GLP-1 RA medications would be low,” Phan noted. “This was born out of anecdotal experience of the limited number of aborted procedures we experienced before the ASA statement.”
Her group also hypothesized that the indication for which the GLP-1 RA was prescribed would be important, with patients taking GLP-1 RA medications for diabetes potentially having a higher likelihood of retained contents given the concomitant propensity for delayed gastric motility related to uncontrolled hyperglycemia.
The Study
The investigators identified 815 patients on confirmed GLP-1 RA medications of various types receiving endoscopy from 2021 to 2023 at four centers. Demographics, prescribing practices, and procedure outcomes were captured. GLP-1 RA management of preoperative holding was retroactively classified per ASA guidance.
Of the 815 patients (mean age, 67.7 years; 57.7% women; 53.9% White individuals), 70 (8.7%) exhibited retained gastric contents on endoscopy. Of these 65 (93%) had T2D with a median A1c of 6.5%. Among those with retained contents, most had a minimal (10, 14.3%) or moderate (31, 44.3%) amount of food retained, although 29 (41.4%) had a large quantity. Only one patient required unplanned intubation because of a large quantity of residual content, and none had aspiration events.
In multivariate analysis, the odds ratio of retention in those with diabetes was 4.1. “Given the predominance of diabetes in those with retained gastric contents, we highlight the potential to risk-stratify patients who require further preprocedural consideration,” the authors wrote.
Those with GLP-1 RA held per ASA guidance (406, 49.8%) were less likely to have retained contents (4.4% vs 12.7%; P < .001), but no significant differences for intubation (0% vs 2%; P = .53) or aborting procedure rates (28% vs 18%; P = .40) due to gastric retention were observed.
On multivariable analysis, the likelihood of food retention increased by 36% (95% CI, 1.15-1.60) for every 1% increase in glycosylated hemoglobin after adjusting for GLP-1 RA type and preoperative medication hold.
“Our study can help to differentiate which patients can be at largest risk for retained gastric contents,” Phan said, noting the impact of increasing percentages of A1C. “There’s a 36% increased likelihood of food retention in patients on GLP-1 medications, so a blanket policy to hold GLP-1s in patients who are nondiabetic and taking the medication for obesity may not be the best approach. But if patients have uncontrolled hyperglycemia, then an approach of caution is clinically valid.” In that context, holding the GLP-1 RA injection or lengthening the preoperative clear-liquid diet policy should be considered.
She noted that the study results are generalizable because the study was conducted across multiple types of hospital systems, both university and county, and included all types of GLP-1 RA.
Offering an anesthesiologist’s perspective on the study, Paul Potnuru, MD, an assistant professor in the Department of Anesthesiology, Critical Care, and Pain Medicine at UTHealth Houston and not involved in the study, called the findings “somewhat reassuring” but said the risk for aspiration was still a consideration.
A recent review, however, reported that the risk for GLP-1 RA-associated pulmonary aspiration was low.
Potnuru acknowledged that the original ASA guidance on preoperative GLP-1 RA cessation led to some confusion. “There were not a lot of data on the issue, but some studies found that even with stopping GLP-1s 2 weeks preoperatively some patients still retained gastric content,” he told GI & Hepatology News.
A study at his center recently reported that 56% of GLP-1 RA users had increased pre-anesthesia residual gastric content compared with 19% of nonusers.
From the anesthesiologist’s clinical vantage point, the margin of safety is an issue even if aspiration risk is low. “If there’s a 1 in 1000 chance or even a 1 in 3000 chance, that can be considered too high,” Potnuru said.
He further noted that the current study included only 815 patients, not nearly enough for definitive data. In addition, a retrospective study based on medical records can’t really capture all the real-world procedural changes made in the operating room. “It’s common for anesthesiologists not to document all cases of intubation, for example,” he said.
While the ideal is a completely empty stomach, he agreed that a practical alternative to stopping GLP-1 RA therapy, especially that prescribed for diabetes, would be a 24-hour liquid diet, which would clear the stomach quickly. “If you stop these drugs in patients taking them for diabetes, you get a worsening of their glycemic control,” he said.
He noted that patients have different risk tolerances, with some willing to go ahead even if ultrasound shows gastric retention, while some opt to cancel.
Prospective studies are needed, Potnuru added, “because you find more if you know what you’re looking for.” His center is starting a clinical trial in 150 patients to assess the impact of a 24-hour, liquids-only diet on gastric retention.
According to Phan, other research is following GLP-1 RA users undergoing colonoscopy. “Future studies can look at the added value of point-of-care abdominal ultrasound to see if it increases precision preoperative management in these patients on GLP-1 medications.”
Other groups are examining the safety of these agents in the general context of sedation. “It’s worth noting that the studies are being done on currently available medications and may not apply to future medications such as triple agonists or anti-amylins that may come on the market in the near future,” Phan said.
This study received no financial support. Neither the study authors nor Potnuru had any conflicts of interest.
A version of this article appeared on Medscape.com.
Eradicating H Pylori Cuts Long-Term Gastric Cancer Risk
Helicobacter pylori (HP) eradication reduced the risk of gastric noncardia adenocarcinoma in five Scandinavian countries, a population-based study in Gastroenterology reported. Risk became virtually similar to the background population from 11 years after treatment onward.
HP infection of the stomach is the main established risk factor for this tumor, but not much was known about the impact of eradication on long-term risk, particularly in Western populations, noted investigators led by Jesper Lagengren, MD, a gastrointestinal surgeon and professor at the Karolinksa Institutet in Stockholm, Sweden. Research with longer follow-up has reported contradictory results.
The study cohort included all adults treated for HP from 1995 to 2019 in Denmark, Finland, Iceland, Norway, and Sweden. Standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) were calculated by comparing the gastric noncardia adenocarcinoma incidence in the study cohort with the incidence in the background population of the same age, sex, calendar period, and country.
The 659,592 treated participants were 54.3% women, 61.5% age 50 or younger, and had no serious comorbidities. They contributed to 5,480,873 person-years at risk with a mean follow-up of 8.3 years. Treatment consisted of a minimum one-week antibiotic regimen with two of amoxicillin, clarithromycin, or metronidazole, in combination with a proton pump inhibitor. This is the recommended regimen in the Nordic countries, where it achieves successful eradication in 90% of infected individuals.
Among these patients, 1311 developed gastric noncardia adenocarcinoma. Over as many as 24 years of follow-up, the SIR in treated HP patients was initially significantly higher than in the background population at 2.27 (95% confidence interval [CI], 2.10-2.44) at 1 to 5 years after treatment. By 6 to 10 years the SIR had dropped to 1.34 (1.21-1.48) and by 11 to 24 years it further fell to 1.11 (.98-1.27). In terms of observed vs expected cases, that translated to 702 vs 310 at 1 to 5 years, 374 vs 270 at 6 to 10 years, and 235 vs 211 from 11 to 24 years.
The results of the Nordic study align with systematic reviews from Asian populations indicating that eradication reduces the risk of gastric cancer, the authors said.
They noted gastric HP infection is the most prevalent bacterial infection worldwide, found in approximately 50% of the global population but with striking geographical variations in prevalence and virulence. The highest prevalence (>80%) and virulence are found in countries with low socioeconomic status and sanitation standards such as regions in Africa and Western Asia.
Gastric adenocarcinoma is the fourth-commonest cause of cancer-related death globally, leading to 660,000 deaths in 2022.
Lagergren and colleagues cited the need for research to delineate high-risk individuals who would benefit rom HP screening and eradication.
This study was supported by the Sjoberg Foundation, Nordic Cancer Union, Stockholm County Council, and Stockholm Cancer Society. The authors had no conflicts of interest to disclose.
Helicobacter pylori (HP) eradication reduced the risk of gastric noncardia adenocarcinoma in five Scandinavian countries, a population-based study in Gastroenterology reported. Risk became virtually similar to the background population from 11 years after treatment onward.
HP infection of the stomach is the main established risk factor for this tumor, but not much was known about the impact of eradication on long-term risk, particularly in Western populations, noted investigators led by Jesper Lagengren, MD, a gastrointestinal surgeon and professor at the Karolinksa Institutet in Stockholm, Sweden. Research with longer follow-up has reported contradictory results.
The study cohort included all adults treated for HP from 1995 to 2019 in Denmark, Finland, Iceland, Norway, and Sweden. Standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) were calculated by comparing the gastric noncardia adenocarcinoma incidence in the study cohort with the incidence in the background population of the same age, sex, calendar period, and country.
The 659,592 treated participants were 54.3% women, 61.5% age 50 or younger, and had no serious comorbidities. They contributed to 5,480,873 person-years at risk with a mean follow-up of 8.3 years. Treatment consisted of a minimum one-week antibiotic regimen with two of amoxicillin, clarithromycin, or metronidazole, in combination with a proton pump inhibitor. This is the recommended regimen in the Nordic countries, where it achieves successful eradication in 90% of infected individuals.
Among these patients, 1311 developed gastric noncardia adenocarcinoma. Over as many as 24 years of follow-up, the SIR in treated HP patients was initially significantly higher than in the background population at 2.27 (95% confidence interval [CI], 2.10-2.44) at 1 to 5 years after treatment. By 6 to 10 years the SIR had dropped to 1.34 (1.21-1.48) and by 11 to 24 years it further fell to 1.11 (.98-1.27). In terms of observed vs expected cases, that translated to 702 vs 310 at 1 to 5 years, 374 vs 270 at 6 to 10 years, and 235 vs 211 from 11 to 24 years.
The results of the Nordic study align with systematic reviews from Asian populations indicating that eradication reduces the risk of gastric cancer, the authors said.
They noted gastric HP infection is the most prevalent bacterial infection worldwide, found in approximately 50% of the global population but with striking geographical variations in prevalence and virulence. The highest prevalence (>80%) and virulence are found in countries with low socioeconomic status and sanitation standards such as regions in Africa and Western Asia.
Gastric adenocarcinoma is the fourth-commonest cause of cancer-related death globally, leading to 660,000 deaths in 2022.
Lagergren and colleagues cited the need for research to delineate high-risk individuals who would benefit rom HP screening and eradication.
This study was supported by the Sjoberg Foundation, Nordic Cancer Union, Stockholm County Council, and Stockholm Cancer Society. The authors had no conflicts of interest to disclose.
Helicobacter pylori (HP) eradication reduced the risk of gastric noncardia adenocarcinoma in five Scandinavian countries, a population-based study in Gastroenterology reported. Risk became virtually similar to the background population from 11 years after treatment onward.
HP infection of the stomach is the main established risk factor for this tumor, but not much was known about the impact of eradication on long-term risk, particularly in Western populations, noted investigators led by Jesper Lagengren, MD, a gastrointestinal surgeon and professor at the Karolinksa Institutet in Stockholm, Sweden. Research with longer follow-up has reported contradictory results.
The study cohort included all adults treated for HP from 1995 to 2019 in Denmark, Finland, Iceland, Norway, and Sweden. Standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) were calculated by comparing the gastric noncardia adenocarcinoma incidence in the study cohort with the incidence in the background population of the same age, sex, calendar period, and country.
The 659,592 treated participants were 54.3% women, 61.5% age 50 or younger, and had no serious comorbidities. They contributed to 5,480,873 person-years at risk with a mean follow-up of 8.3 years. Treatment consisted of a minimum one-week antibiotic regimen with two of amoxicillin, clarithromycin, or metronidazole, in combination with a proton pump inhibitor. This is the recommended regimen in the Nordic countries, where it achieves successful eradication in 90% of infected individuals.
Among these patients, 1311 developed gastric noncardia adenocarcinoma. Over as many as 24 years of follow-up, the SIR in treated HP patients was initially significantly higher than in the background population at 2.27 (95% confidence interval [CI], 2.10-2.44) at 1 to 5 years after treatment. By 6 to 10 years the SIR had dropped to 1.34 (1.21-1.48) and by 11 to 24 years it further fell to 1.11 (.98-1.27). In terms of observed vs expected cases, that translated to 702 vs 310 at 1 to 5 years, 374 vs 270 at 6 to 10 years, and 235 vs 211 from 11 to 24 years.
The results of the Nordic study align with systematic reviews from Asian populations indicating that eradication reduces the risk of gastric cancer, the authors said.
They noted gastric HP infection is the most prevalent bacterial infection worldwide, found in approximately 50% of the global population but with striking geographical variations in prevalence and virulence. The highest prevalence (>80%) and virulence are found in countries with low socioeconomic status and sanitation standards such as regions in Africa and Western Asia.
Gastric adenocarcinoma is the fourth-commonest cause of cancer-related death globally, leading to 660,000 deaths in 2022.
Lagergren and colleagues cited the need for research to delineate high-risk individuals who would benefit rom HP screening and eradication.
This study was supported by the Sjoberg Foundation, Nordic Cancer Union, Stockholm County Council, and Stockholm Cancer Society. The authors had no conflicts of interest to disclose.
FROM GASTROENTEROLOGY
Neighborhood Determinants of Health Adversely Impact MASLD
These health mediators should be considered along with individual SDOH in clinical care and healthcare quality and equity improvement, a large retrospective study of adults with MASLD at a multi-state healthcare institution concluded.
Across quartiles, patients in the most disadvantaged neighborhoods (according to home addresses) vs the least disadvantaged had worse outcomes and were also disproportionately Hispanic, Black, and Native American/Alaska Native, more often Spanish-speaking in primary language, and more often uninsured or on Medicaid, according to Karn Wijarnpreecha, MD, MPH, of the Division of Gastroenterology and Hepatology at University of Arizona College of Medicine–Phoenix, and colleagues writing in Clinical Gastroenterology and Hepatology.
Even after adjustment for measures in the Social Deprivation Index (SDI), the incidence of death, cirrhosis, diabetes mellitus (DM), and major adverse cardiovascular events (MACE) was higher in Native American/Alaska Native patients compared with their non-Hispanic White counterparts. The SDI is a composite measure of seven demographic characteristics from the American Community Survey, with scores ranging from 1 to 100 and weighted based on characteristics from national percentile rankings.
Aligning with the growing prevalence of obesity and DM, MASLD has increased substantially over the past three decades, and is now the leading cause of chronic liver disease in this country and the world.
This rise in prevalence has underscored health disparities in MASLD and prompted research into linkd between liver disease and SDOH, defined as the conditions under which people are born, grow, live, work, and age. These are fundamental drivers of health disparities, including those in MASLD.
Study Details
Primary outcomes were MASLD burden, mortality, and comorbidities by neighborhood SDOH, assessed using the SDI in cross-sectional and longitudinal analyses.
A total of 69,191 adult patients (more than 50% female) diagnosed with MASLD were included, 45,003 of whom had at least 365 days of follow-up. They were treated from July 2012 to June 2023 in Banner Health Systems, a network that includes primary-, secondary-, and tertiary-care centers in Arizona, Colorado, Wyoming, Nevada, Nebraska, and California.
The median follow-up time was 48 months. Among patients across SDI quartiles (age range 49 to 62 years), 1390 patients (3.1%) died, 902 (2.0%) developed cirrhosis, 1087 (2.4%) developed LRE, 6537 (14.5%) developed DM, 2057 (4.6%) developed cancer, and 5409 (12.0%) developed MACE.
Those living in the most disadvantaged quartile of neighborhoods compared with the least had the following higher odds:
- cirrhosis, adjusted odds ratio [aOR], 1.42 (P < .001)
- any cardiovascular (CVD) disease, aOR, 1.20 (P < .001),
- coronary artery disease, aOR, 1.17 (P < .001)
- congestive heart failure, aOR, 1.43 (P < .001)
- cerebrovascular accident, aOR, 1.19 (P = .001)
- DM, aOR, 1.57 (P < .001)
- hypertension, aOR, 1.38 (P < .001).
They also had increased incidence of death (adjusted hazard ratio [aHR], 1.47; P < .001), LRE (aHR, 1.31; P = .012), DM (aHR, 1.47; P < .001), and MACE (aHR, 1.24; P < .001).
The study expands upon previous SDOH-related research in liver disease and is the largest analysis of neighborhood-level SDOH in patients with MASLD to date. “Our findings are consistent with a recent study by Chen et al of over 15,900 patients with MASLD in Michigan that found neighborhood-level social disadvantage was associated with increased mortality and incident LREs and CVD,” Wijarnpreecha and colleagues wrote.
“Beyond screening patients for individual-level SDOH, neighborhood-level determinants of health should also be considered, as they are important mediators between the environment and the individual,” they added, calling for studies to better understand the specific neighborhood SDOH that drive the disparate outcomes. In practice, integration of these measures into medical records might inform clinicians which patients would benefit from social services or help guide quality improvement projects and community partnerships.
Wijarnpreecha had no conflicts of interest to disclose. Several coauthors reported research support, consulting/advisory work, or stock ownership for various private-sector companies.
The sprectrum of steatotic liver disease (SLD) including metabolic dysfunction associated steatotic liver disease (MASLD) is increasing in the United Statues. 38% of adults and 7-14% of children currently have MASLD and it is projected that by 2040 the prevalence rate for MASLD will be higher than 55% in US adults. Fortunately, most will not develop serious liver disease. However, even a small subset is impacted, significant liver related morbidity and mortality will be the result.
Yet, concentrating only on the liver misses the substantial impact of other metabolic outcomes associated with MASLD. Equally important, at risk MASLD is treatable with lifestyle modifications, pharmacotherapy and surgical options which improve liver related outcomes, metabolic complications, and all-cause mortality. When over half of the US has a disease that requires individuals to navigate a complex care pathway that includes screening, staging, and risk modification across multiple metabolic conditions, any factor that can help identify those in need for targeted interventions is paramount. And personalization that allows someone to effectively traverse the care pathway allows for the most successful outcome.
Social determinants of health (SDOH) are complex but not insurmountable. By recognizing the contribution of SDOH, studies can be designed to discover which factors drive disparate outcomes on a granular level. This can then support funding and policy changes to address these elements. It is already well established that food insecurity is associated with both prevalence of MASLD and liver-related mortality. Policies to address the issues related to poverty can be prioritized and their impact measured.
This study also highlights the importance of needs by neighborhood. Culture has an impact on diet which is inextricably linked to MASLD. Acculturation, or the process of adapting to a new culture, is associated with poor health, physical inactivity, and poor diet but is also recognized. Western diets are high in saturated fat and refined carbohydrates which then increase risk of obesity and MASLD. In neighborhoods where culturally tailored interventions can improve health outcomes, community-based programs are imperative. In conclusion, a holistic approach that acknowledges and integrates cultural practices and preferences into MASLD prevention and management strategies can improve treatment adherence and outcomes, particularly for high-risk populations.
Nancy S. Reau, MD, AGAF, is professor and section chief of hepatology in the Division of Digestive Diseases and Nutrition at Rush University, Chicago. She has no disclosures in relation to this commentary.
The sprectrum of steatotic liver disease (SLD) including metabolic dysfunction associated steatotic liver disease (MASLD) is increasing in the United Statues. 38% of adults and 7-14% of children currently have MASLD and it is projected that by 2040 the prevalence rate for MASLD will be higher than 55% in US adults. Fortunately, most will not develop serious liver disease. However, even a small subset is impacted, significant liver related morbidity and mortality will be the result.
Yet, concentrating only on the liver misses the substantial impact of other metabolic outcomes associated with MASLD. Equally important, at risk MASLD is treatable with lifestyle modifications, pharmacotherapy and surgical options which improve liver related outcomes, metabolic complications, and all-cause mortality. When over half of the US has a disease that requires individuals to navigate a complex care pathway that includes screening, staging, and risk modification across multiple metabolic conditions, any factor that can help identify those in need for targeted interventions is paramount. And personalization that allows someone to effectively traverse the care pathway allows for the most successful outcome.
Social determinants of health (SDOH) are complex but not insurmountable. By recognizing the contribution of SDOH, studies can be designed to discover which factors drive disparate outcomes on a granular level. This can then support funding and policy changes to address these elements. It is already well established that food insecurity is associated with both prevalence of MASLD and liver-related mortality. Policies to address the issues related to poverty can be prioritized and their impact measured.
This study also highlights the importance of needs by neighborhood. Culture has an impact on diet which is inextricably linked to MASLD. Acculturation, or the process of adapting to a new culture, is associated with poor health, physical inactivity, and poor diet but is also recognized. Western diets are high in saturated fat and refined carbohydrates which then increase risk of obesity and MASLD. In neighborhoods where culturally tailored interventions can improve health outcomes, community-based programs are imperative. In conclusion, a holistic approach that acknowledges and integrates cultural practices and preferences into MASLD prevention and management strategies can improve treatment adherence and outcomes, particularly for high-risk populations.
Nancy S. Reau, MD, AGAF, is professor and section chief of hepatology in the Division of Digestive Diseases and Nutrition at Rush University, Chicago. She has no disclosures in relation to this commentary.
The sprectrum of steatotic liver disease (SLD) including metabolic dysfunction associated steatotic liver disease (MASLD) is increasing in the United Statues. 38% of adults and 7-14% of children currently have MASLD and it is projected that by 2040 the prevalence rate for MASLD will be higher than 55% in US adults. Fortunately, most will not develop serious liver disease. However, even a small subset is impacted, significant liver related morbidity and mortality will be the result.
Yet, concentrating only on the liver misses the substantial impact of other metabolic outcomes associated with MASLD. Equally important, at risk MASLD is treatable with lifestyle modifications, pharmacotherapy and surgical options which improve liver related outcomes, metabolic complications, and all-cause mortality. When over half of the US has a disease that requires individuals to navigate a complex care pathway that includes screening, staging, and risk modification across multiple metabolic conditions, any factor that can help identify those in need for targeted interventions is paramount. And personalization that allows someone to effectively traverse the care pathway allows for the most successful outcome.
Social determinants of health (SDOH) are complex but not insurmountable. By recognizing the contribution of SDOH, studies can be designed to discover which factors drive disparate outcomes on a granular level. This can then support funding and policy changes to address these elements. It is already well established that food insecurity is associated with both prevalence of MASLD and liver-related mortality. Policies to address the issues related to poverty can be prioritized and their impact measured.
This study also highlights the importance of needs by neighborhood. Culture has an impact on diet which is inextricably linked to MASLD. Acculturation, or the process of adapting to a new culture, is associated with poor health, physical inactivity, and poor diet but is also recognized. Western diets are high in saturated fat and refined carbohydrates which then increase risk of obesity and MASLD. In neighborhoods where culturally tailored interventions can improve health outcomes, community-based programs are imperative. In conclusion, a holistic approach that acknowledges and integrates cultural practices and preferences into MASLD prevention and management strategies can improve treatment adherence and outcomes, particularly for high-risk populations.
Nancy S. Reau, MD, AGAF, is professor and section chief of hepatology in the Division of Digestive Diseases and Nutrition at Rush University, Chicago. She has no disclosures in relation to this commentary.
These health mediators should be considered along with individual SDOH in clinical care and healthcare quality and equity improvement, a large retrospective study of adults with MASLD at a multi-state healthcare institution concluded.
Across quartiles, patients in the most disadvantaged neighborhoods (according to home addresses) vs the least disadvantaged had worse outcomes and were also disproportionately Hispanic, Black, and Native American/Alaska Native, more often Spanish-speaking in primary language, and more often uninsured or on Medicaid, according to Karn Wijarnpreecha, MD, MPH, of the Division of Gastroenterology and Hepatology at University of Arizona College of Medicine–Phoenix, and colleagues writing in Clinical Gastroenterology and Hepatology.
Even after adjustment for measures in the Social Deprivation Index (SDI), the incidence of death, cirrhosis, diabetes mellitus (DM), and major adverse cardiovascular events (MACE) was higher in Native American/Alaska Native patients compared with their non-Hispanic White counterparts. The SDI is a composite measure of seven demographic characteristics from the American Community Survey, with scores ranging from 1 to 100 and weighted based on characteristics from national percentile rankings.
Aligning with the growing prevalence of obesity and DM, MASLD has increased substantially over the past three decades, and is now the leading cause of chronic liver disease in this country and the world.
This rise in prevalence has underscored health disparities in MASLD and prompted research into linkd between liver disease and SDOH, defined as the conditions under which people are born, grow, live, work, and age. These are fundamental drivers of health disparities, including those in MASLD.
Study Details
Primary outcomes were MASLD burden, mortality, and comorbidities by neighborhood SDOH, assessed using the SDI in cross-sectional and longitudinal analyses.
A total of 69,191 adult patients (more than 50% female) diagnosed with MASLD were included, 45,003 of whom had at least 365 days of follow-up. They were treated from July 2012 to June 2023 in Banner Health Systems, a network that includes primary-, secondary-, and tertiary-care centers in Arizona, Colorado, Wyoming, Nevada, Nebraska, and California.
The median follow-up time was 48 months. Among patients across SDI quartiles (age range 49 to 62 years), 1390 patients (3.1%) died, 902 (2.0%) developed cirrhosis, 1087 (2.4%) developed LRE, 6537 (14.5%) developed DM, 2057 (4.6%) developed cancer, and 5409 (12.0%) developed MACE.
Those living in the most disadvantaged quartile of neighborhoods compared with the least had the following higher odds:
- cirrhosis, adjusted odds ratio [aOR], 1.42 (P < .001)
- any cardiovascular (CVD) disease, aOR, 1.20 (P < .001),
- coronary artery disease, aOR, 1.17 (P < .001)
- congestive heart failure, aOR, 1.43 (P < .001)
- cerebrovascular accident, aOR, 1.19 (P = .001)
- DM, aOR, 1.57 (P < .001)
- hypertension, aOR, 1.38 (P < .001).
They also had increased incidence of death (adjusted hazard ratio [aHR], 1.47; P < .001), LRE (aHR, 1.31; P = .012), DM (aHR, 1.47; P < .001), and MACE (aHR, 1.24; P < .001).
The study expands upon previous SDOH-related research in liver disease and is the largest analysis of neighborhood-level SDOH in patients with MASLD to date. “Our findings are consistent with a recent study by Chen et al of over 15,900 patients with MASLD in Michigan that found neighborhood-level social disadvantage was associated with increased mortality and incident LREs and CVD,” Wijarnpreecha and colleagues wrote.
“Beyond screening patients for individual-level SDOH, neighborhood-level determinants of health should also be considered, as they are important mediators between the environment and the individual,” they added, calling for studies to better understand the specific neighborhood SDOH that drive the disparate outcomes. In practice, integration of these measures into medical records might inform clinicians which patients would benefit from social services or help guide quality improvement projects and community partnerships.
Wijarnpreecha had no conflicts of interest to disclose. Several coauthors reported research support, consulting/advisory work, or stock ownership for various private-sector companies.
These health mediators should be considered along with individual SDOH in clinical care and healthcare quality and equity improvement, a large retrospective study of adults with MASLD at a multi-state healthcare institution concluded.
Across quartiles, patients in the most disadvantaged neighborhoods (according to home addresses) vs the least disadvantaged had worse outcomes and were also disproportionately Hispanic, Black, and Native American/Alaska Native, more often Spanish-speaking in primary language, and more often uninsured or on Medicaid, according to Karn Wijarnpreecha, MD, MPH, of the Division of Gastroenterology and Hepatology at University of Arizona College of Medicine–Phoenix, and colleagues writing in Clinical Gastroenterology and Hepatology.
Even after adjustment for measures in the Social Deprivation Index (SDI), the incidence of death, cirrhosis, diabetes mellitus (DM), and major adverse cardiovascular events (MACE) was higher in Native American/Alaska Native patients compared with their non-Hispanic White counterparts. The SDI is a composite measure of seven demographic characteristics from the American Community Survey, with scores ranging from 1 to 100 and weighted based on characteristics from national percentile rankings.
Aligning with the growing prevalence of obesity and DM, MASLD has increased substantially over the past three decades, and is now the leading cause of chronic liver disease in this country and the world.
This rise in prevalence has underscored health disparities in MASLD and prompted research into linkd between liver disease and SDOH, defined as the conditions under which people are born, grow, live, work, and age. These are fundamental drivers of health disparities, including those in MASLD.
Study Details
Primary outcomes were MASLD burden, mortality, and comorbidities by neighborhood SDOH, assessed using the SDI in cross-sectional and longitudinal analyses.
A total of 69,191 adult patients (more than 50% female) diagnosed with MASLD were included, 45,003 of whom had at least 365 days of follow-up. They were treated from July 2012 to June 2023 in Banner Health Systems, a network that includes primary-, secondary-, and tertiary-care centers in Arizona, Colorado, Wyoming, Nevada, Nebraska, and California.
The median follow-up time was 48 months. Among patients across SDI quartiles (age range 49 to 62 years), 1390 patients (3.1%) died, 902 (2.0%) developed cirrhosis, 1087 (2.4%) developed LRE, 6537 (14.5%) developed DM, 2057 (4.6%) developed cancer, and 5409 (12.0%) developed MACE.
Those living in the most disadvantaged quartile of neighborhoods compared with the least had the following higher odds:
- cirrhosis, adjusted odds ratio [aOR], 1.42 (P < .001)
- any cardiovascular (CVD) disease, aOR, 1.20 (P < .001),
- coronary artery disease, aOR, 1.17 (P < .001)
- congestive heart failure, aOR, 1.43 (P < .001)
- cerebrovascular accident, aOR, 1.19 (P = .001)
- DM, aOR, 1.57 (P < .001)
- hypertension, aOR, 1.38 (P < .001).
They also had increased incidence of death (adjusted hazard ratio [aHR], 1.47; P < .001), LRE (aHR, 1.31; P = .012), DM (aHR, 1.47; P < .001), and MACE (aHR, 1.24; P < .001).
The study expands upon previous SDOH-related research in liver disease and is the largest analysis of neighborhood-level SDOH in patients with MASLD to date. “Our findings are consistent with a recent study by Chen et al of over 15,900 patients with MASLD in Michigan that found neighborhood-level social disadvantage was associated with increased mortality and incident LREs and CVD,” Wijarnpreecha and colleagues wrote.
“Beyond screening patients for individual-level SDOH, neighborhood-level determinants of health should also be considered, as they are important mediators between the environment and the individual,” they added, calling for studies to better understand the specific neighborhood SDOH that drive the disparate outcomes. In practice, integration of these measures into medical records might inform clinicians which patients would benefit from social services or help guide quality improvement projects and community partnerships.
Wijarnpreecha had no conflicts of interest to disclose. Several coauthors reported research support, consulting/advisory work, or stock ownership for various private-sector companies.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Endoscopic Lifting Agents: AGA Issues New Clinical Practice Update
Published in Clinical Gastroenterology and Hepatology, the commentary reviews available agents and provides clinically relevant commentary on their indications and use — with the caveat that it is not a formal systematic review but rather empirical advice for endoscopists. No formal rating of the quality of evidence or strength of recommendations was performed.
Led by Tobias Zuchelli, MD, a clinical associate professor at Michigan State University and a gastroenterologist at the Henry Ford Health System in Detroit, the expert panel noted that endoscopists are increasingly resecting precancerous lesions and early cancers of the gastrointestinal tract.
“Although new endoscopic procedures have been developed, there had not been much in terms of high-quality guidance on lifting agents,” panelist Amit V. Patel, MD, a professor of medicine at Duke University and director of Endoscopy at Durham Veterans Affairs Medical Center in Durham, North Carolina, told GI & Hepatology News. “With our better understanding and use of techniques, this commentary was timely. It summarizes the available data on the topic and includes our clinical experiences.”
Filling that knowledge gap, the document reviews in detail the timing and methods of agent injection according to procedure type, including the dynamic needle approach, the empirical merits of different agents such as saline (with or without blue contrast) and viscous agents, as well as lift-enhancing assistive devices — for example, the ERBEJET 2 high-pressure water jet, an adjustable hydrosurgical device to facilitate lifting. A chart provides an at-a-glance summary of agents and their pros and cons.
“The feedback from gastroenterologists so far has been quite positive on social media and on GI channels,” Patel said.
Endoscopic resection has evolved from snare polypectomy to endoscopic mucosal resection (EMR) and now, endoscopic submucosal dissection (ESD). The primary benefit of submucosal lifting is the creation of a separating submucosal cushion between the lesion and muscularis propria (MP), which reduces the risk for immediate or delayed perforation of the muscle. Adding a contrast agent also demarcates lesion margins and stains the submucosa, which is fundamental to ESD and allows for assessment of MP injury during EMR.
For decades, homemade solutions were used to lift lesions before removal, with the sentinel agent being normal saline, later mixed with a blue contrast agent, usually indigo carmine or methylene blue. The authors noted that some endoscopists performing ESD start the submucosal injection and incision using a prepackaged viscous solution. “The endoscopist may continue with the viscous fluid or transition to saline or another less expensive solution,” they wrote.
Saline tends to dissipate more quickly than viscous solutions, however. In 2015, the polymer compound SIC-8000 became the first FDA-approved submucosal injection agent. Since then, several other fluids have come on the market, although homemade agents remain available.
Among the update’s recommendations, the fluid selected for EMR should be determined by lesion size, predicted histology, and endoscopist preference. Based on the US Multi-Society Task Force (USMSTF) on Colorectal Cancer, submucosal injection is optional for nonpedunculated colorectal lesions (NPCRLs) of intermediate size (10-19 mm).
Cold snare polypectomy without submucosal injection was later found to be non-inferior to other resection methods utilizing submucosal injection for NPCRLs ≤ 15 mm.
The update noted that the USMSTF considers EMR first-line therapy for most NPCRLs ≥ 20 mm and advocates viscous solutions as preferred, while the use of lifting agents for pedunculated polyps is generally at the discretion of the endoscopist.
For Patel, the main “clinical pearls” in the update are adding a contrast agent to normal saline, using a viscous agent for cold EMR, and manipulating the injection needle first tangentially and then dynamically toward the lumen to maximize separation of the lesion.
In terms of the ideal, an optimal lifting solution would be readily available, inexpensive, and premixed, providing a sustained submucosal cushion. “However, this ideal solution currently does not exist. Injection fluids should, therefore, be selected based on planned resection method, predicted histology, local expertise and preferences, and cost,” the panelists wrote.
Added Patel, “A lot of the agents out there check most of these boxes, but we’re hoping for further development toward the ideal.”
Offering a nonparticipant’s perspective on the overview, Wasseem Skef, MD, a gastroenterologist at UTHealth Houston, found the update very useful. “It always helps to have the literature summarized,” he told GI & Hepatology News. “It’s a pretty balanced review that pulls together the various options but allows people to stick to their preferred practice.”
In his practice, the lifting agent selected depends on the type of resection. “Viscous agents are generally more popular for EMR-type resections,” Skef said. One unanswered question, he noted, is whether adding a hemostatic agent would be superior to a viscous agent alone. “But overall, this is a nice summary of available agents. Gastroenterologists should consider these different options if doing procedures like EMR.”
This review was sponsored by the AGA Institute.
Zuchelli is a consultant for Boston Scientific. Patel consults for Medpace, Renexxion, and Sanofi. Skef reported having no relevant disclosures.
A version of this article appeared on Medscape.com .
Published in Clinical Gastroenterology and Hepatology, the commentary reviews available agents and provides clinically relevant commentary on their indications and use — with the caveat that it is not a formal systematic review but rather empirical advice for endoscopists. No formal rating of the quality of evidence or strength of recommendations was performed.
Led by Tobias Zuchelli, MD, a clinical associate professor at Michigan State University and a gastroenterologist at the Henry Ford Health System in Detroit, the expert panel noted that endoscopists are increasingly resecting precancerous lesions and early cancers of the gastrointestinal tract.
“Although new endoscopic procedures have been developed, there had not been much in terms of high-quality guidance on lifting agents,” panelist Amit V. Patel, MD, a professor of medicine at Duke University and director of Endoscopy at Durham Veterans Affairs Medical Center in Durham, North Carolina, told GI & Hepatology News. “With our better understanding and use of techniques, this commentary was timely. It summarizes the available data on the topic and includes our clinical experiences.”
Filling that knowledge gap, the document reviews in detail the timing and methods of agent injection according to procedure type, including the dynamic needle approach, the empirical merits of different agents such as saline (with or without blue contrast) and viscous agents, as well as lift-enhancing assistive devices — for example, the ERBEJET 2 high-pressure water jet, an adjustable hydrosurgical device to facilitate lifting. A chart provides an at-a-glance summary of agents and their pros and cons.
“The feedback from gastroenterologists so far has been quite positive on social media and on GI channels,” Patel said.
Endoscopic resection has evolved from snare polypectomy to endoscopic mucosal resection (EMR) and now, endoscopic submucosal dissection (ESD). The primary benefit of submucosal lifting is the creation of a separating submucosal cushion between the lesion and muscularis propria (MP), which reduces the risk for immediate or delayed perforation of the muscle. Adding a contrast agent also demarcates lesion margins and stains the submucosa, which is fundamental to ESD and allows for assessment of MP injury during EMR.
For decades, homemade solutions were used to lift lesions before removal, with the sentinel agent being normal saline, later mixed with a blue contrast agent, usually indigo carmine or methylene blue. The authors noted that some endoscopists performing ESD start the submucosal injection and incision using a prepackaged viscous solution. “The endoscopist may continue with the viscous fluid or transition to saline or another less expensive solution,” they wrote.
Saline tends to dissipate more quickly than viscous solutions, however. In 2015, the polymer compound SIC-8000 became the first FDA-approved submucosal injection agent. Since then, several other fluids have come on the market, although homemade agents remain available.
Among the update’s recommendations, the fluid selected for EMR should be determined by lesion size, predicted histology, and endoscopist preference. Based on the US Multi-Society Task Force (USMSTF) on Colorectal Cancer, submucosal injection is optional for nonpedunculated colorectal lesions (NPCRLs) of intermediate size (10-19 mm).
Cold snare polypectomy without submucosal injection was later found to be non-inferior to other resection methods utilizing submucosal injection for NPCRLs ≤ 15 mm.
The update noted that the USMSTF considers EMR first-line therapy for most NPCRLs ≥ 20 mm and advocates viscous solutions as preferred, while the use of lifting agents for pedunculated polyps is generally at the discretion of the endoscopist.
For Patel, the main “clinical pearls” in the update are adding a contrast agent to normal saline, using a viscous agent for cold EMR, and manipulating the injection needle first tangentially and then dynamically toward the lumen to maximize separation of the lesion.
In terms of the ideal, an optimal lifting solution would be readily available, inexpensive, and premixed, providing a sustained submucosal cushion. “However, this ideal solution currently does not exist. Injection fluids should, therefore, be selected based on planned resection method, predicted histology, local expertise and preferences, and cost,” the panelists wrote.
Added Patel, “A lot of the agents out there check most of these boxes, but we’re hoping for further development toward the ideal.”
Offering a nonparticipant’s perspective on the overview, Wasseem Skef, MD, a gastroenterologist at UTHealth Houston, found the update very useful. “It always helps to have the literature summarized,” he told GI & Hepatology News. “It’s a pretty balanced review that pulls together the various options but allows people to stick to their preferred practice.”
In his practice, the lifting agent selected depends on the type of resection. “Viscous agents are generally more popular for EMR-type resections,” Skef said. One unanswered question, he noted, is whether adding a hemostatic agent would be superior to a viscous agent alone. “But overall, this is a nice summary of available agents. Gastroenterologists should consider these different options if doing procedures like EMR.”
This review was sponsored by the AGA Institute.
Zuchelli is a consultant for Boston Scientific. Patel consults for Medpace, Renexxion, and Sanofi. Skef reported having no relevant disclosures.
A version of this article appeared on Medscape.com .
Published in Clinical Gastroenterology and Hepatology, the commentary reviews available agents and provides clinically relevant commentary on their indications and use — with the caveat that it is not a formal systematic review but rather empirical advice for endoscopists. No formal rating of the quality of evidence or strength of recommendations was performed.
Led by Tobias Zuchelli, MD, a clinical associate professor at Michigan State University and a gastroenterologist at the Henry Ford Health System in Detroit, the expert panel noted that endoscopists are increasingly resecting precancerous lesions and early cancers of the gastrointestinal tract.
“Although new endoscopic procedures have been developed, there had not been much in terms of high-quality guidance on lifting agents,” panelist Amit V. Patel, MD, a professor of medicine at Duke University and director of Endoscopy at Durham Veterans Affairs Medical Center in Durham, North Carolina, told GI & Hepatology News. “With our better understanding and use of techniques, this commentary was timely. It summarizes the available data on the topic and includes our clinical experiences.”
Filling that knowledge gap, the document reviews in detail the timing and methods of agent injection according to procedure type, including the dynamic needle approach, the empirical merits of different agents such as saline (with or without blue contrast) and viscous agents, as well as lift-enhancing assistive devices — for example, the ERBEJET 2 high-pressure water jet, an adjustable hydrosurgical device to facilitate lifting. A chart provides an at-a-glance summary of agents and their pros and cons.
“The feedback from gastroenterologists so far has been quite positive on social media and on GI channels,” Patel said.
Endoscopic resection has evolved from snare polypectomy to endoscopic mucosal resection (EMR) and now, endoscopic submucosal dissection (ESD). The primary benefit of submucosal lifting is the creation of a separating submucosal cushion between the lesion and muscularis propria (MP), which reduces the risk for immediate or delayed perforation of the muscle. Adding a contrast agent also demarcates lesion margins and stains the submucosa, which is fundamental to ESD and allows for assessment of MP injury during EMR.
For decades, homemade solutions were used to lift lesions before removal, with the sentinel agent being normal saline, later mixed with a blue contrast agent, usually indigo carmine or methylene blue. The authors noted that some endoscopists performing ESD start the submucosal injection and incision using a prepackaged viscous solution. “The endoscopist may continue with the viscous fluid or transition to saline or another less expensive solution,” they wrote.
Saline tends to dissipate more quickly than viscous solutions, however. In 2015, the polymer compound SIC-8000 became the first FDA-approved submucosal injection agent. Since then, several other fluids have come on the market, although homemade agents remain available.
Among the update’s recommendations, the fluid selected for EMR should be determined by lesion size, predicted histology, and endoscopist preference. Based on the US Multi-Society Task Force (USMSTF) on Colorectal Cancer, submucosal injection is optional for nonpedunculated colorectal lesions (NPCRLs) of intermediate size (10-19 mm).
Cold snare polypectomy without submucosal injection was later found to be non-inferior to other resection methods utilizing submucosal injection for NPCRLs ≤ 15 mm.
The update noted that the USMSTF considers EMR first-line therapy for most NPCRLs ≥ 20 mm and advocates viscous solutions as preferred, while the use of lifting agents for pedunculated polyps is generally at the discretion of the endoscopist.
For Patel, the main “clinical pearls” in the update are adding a contrast agent to normal saline, using a viscous agent for cold EMR, and manipulating the injection needle first tangentially and then dynamically toward the lumen to maximize separation of the lesion.
In terms of the ideal, an optimal lifting solution would be readily available, inexpensive, and premixed, providing a sustained submucosal cushion. “However, this ideal solution currently does not exist. Injection fluids should, therefore, be selected based on planned resection method, predicted histology, local expertise and preferences, and cost,” the panelists wrote.
Added Patel, “A lot of the agents out there check most of these boxes, but we’re hoping for further development toward the ideal.”
Offering a nonparticipant’s perspective on the overview, Wasseem Skef, MD, a gastroenterologist at UTHealth Houston, found the update very useful. “It always helps to have the literature summarized,” he told GI & Hepatology News. “It’s a pretty balanced review that pulls together the various options but allows people to stick to their preferred practice.”
In his practice, the lifting agent selected depends on the type of resection. “Viscous agents are generally more popular for EMR-type resections,” Skef said. One unanswered question, he noted, is whether adding a hemostatic agent would be superior to a viscous agent alone. “But overall, this is a nice summary of available agents. Gastroenterologists should consider these different options if doing procedures like EMR.”
This review was sponsored by the AGA Institute.
Zuchelli is a consultant for Boston Scientific. Patel consults for Medpace, Renexxion, and Sanofi. Skef reported having no relevant disclosures.
A version of this article appeared on Medscape.com .
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
FDA Issues Early Alert for Medtronic pH-Monitoring Capsules
The notice follows two letters sent in June to customers by the devices’ manufacturer Medtronic and its subsidiary Given Imaging Inc., recommending that customers using certain Bravo CF Capsule Delivery Devices (lot numbers below) for esophageal pH monitoring be removed from all sites of use and sale.
All three of the capsule models listed below are thought to pose a potential risk because the capsules fail to attach to the esophagus’s mucosal wall or to detach from the delivery device as intended owing to a misapplication of adhesive during manufacture. The devices transmit pH data to a recorder attached to the waist of the patient, who interacts with the recorder to indicate symptoms, thereby allowing the physician to compare the symptoms with the occurrence of reflux episodes.
Risks associated with the devices include aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
Medtronic has reported 33 serious injuries but no deaths associated with the devices.
The lot numbers of the three affected units, which should be identified and quarantined immediately are:
- Bravo CF Capsule Delivery Device, 5-pk, Product Number FGS-0635, Unique Device Identifier-Device Identifier (UDI-DI) 07290101369707
- Bravo CF Capsule Delivery Device 5-pk, FGS-0635, UDI-DI 10613994000009
- Bravo CF Capsule Delivery Device 1-pk, FGS-0636, UDI-DI 07290101369714
These lot identifiers can be found on both the 5-pks’ FGS-0635 outer labels and on the 1-pk FGS-036 individual unit. Customers are advised to return all unused affected products to Medtronic for replacement or credit. In addition, they should pass on this notice to all those who need to be aware within their organizations or to any organizations to which the affected products have been distributed.
They are also advised to check the FDA recall website above for updates as it continues to review information about this potentially high-risk device issue.
Healthcare professionals with concerns or reports of adverse events can contact Medtronic at 800-448-3644 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
A version of this article appeared on Medscape.com.
The notice follows two letters sent in June to customers by the devices’ manufacturer Medtronic and its subsidiary Given Imaging Inc., recommending that customers using certain Bravo CF Capsule Delivery Devices (lot numbers below) for esophageal pH monitoring be removed from all sites of use and sale.
All three of the capsule models listed below are thought to pose a potential risk because the capsules fail to attach to the esophagus’s mucosal wall or to detach from the delivery device as intended owing to a misapplication of adhesive during manufacture. The devices transmit pH data to a recorder attached to the waist of the patient, who interacts with the recorder to indicate symptoms, thereby allowing the physician to compare the symptoms with the occurrence of reflux episodes.
Risks associated with the devices include aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
Medtronic has reported 33 serious injuries but no deaths associated with the devices.
The lot numbers of the three affected units, which should be identified and quarantined immediately are:
- Bravo CF Capsule Delivery Device, 5-pk, Product Number FGS-0635, Unique Device Identifier-Device Identifier (UDI-DI) 07290101369707
- Bravo CF Capsule Delivery Device 5-pk, FGS-0635, UDI-DI 10613994000009
- Bravo CF Capsule Delivery Device 1-pk, FGS-0636, UDI-DI 07290101369714
These lot identifiers can be found on both the 5-pks’ FGS-0635 outer labels and on the 1-pk FGS-036 individual unit. Customers are advised to return all unused affected products to Medtronic for replacement or credit. In addition, they should pass on this notice to all those who need to be aware within their organizations or to any organizations to which the affected products have been distributed.
They are also advised to check the FDA recall website above for updates as it continues to review information about this potentially high-risk device issue.
Healthcare professionals with concerns or reports of adverse events can contact Medtronic at 800-448-3644 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
A version of this article appeared on Medscape.com.
The notice follows two letters sent in June to customers by the devices’ manufacturer Medtronic and its subsidiary Given Imaging Inc., recommending that customers using certain Bravo CF Capsule Delivery Devices (lot numbers below) for esophageal pH monitoring be removed from all sites of use and sale.
All three of the capsule models listed below are thought to pose a potential risk because the capsules fail to attach to the esophagus’s mucosal wall or to detach from the delivery device as intended owing to a misapplication of adhesive during manufacture. The devices transmit pH data to a recorder attached to the waist of the patient, who interacts with the recorder to indicate symptoms, thereby allowing the physician to compare the symptoms with the occurrence of reflux episodes.
Risks associated with the devices include aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
Medtronic has reported 33 serious injuries but no deaths associated with the devices.
The lot numbers of the three affected units, which should be identified and quarantined immediately are:
- Bravo CF Capsule Delivery Device, 5-pk, Product Number FGS-0635, Unique Device Identifier-Device Identifier (UDI-DI) 07290101369707
- Bravo CF Capsule Delivery Device 5-pk, FGS-0635, UDI-DI 10613994000009
- Bravo CF Capsule Delivery Device 1-pk, FGS-0636, UDI-DI 07290101369714
These lot identifiers can be found on both the 5-pks’ FGS-0635 outer labels and on the 1-pk FGS-036 individual unit. Customers are advised to return all unused affected products to Medtronic for replacement or credit. In addition, they should pass on this notice to all those who need to be aware within their organizations or to any organizations to which the affected products have been distributed.
They are also advised to check the FDA recall website above for updates as it continues to review information about this potentially high-risk device issue.
Healthcare professionals with concerns or reports of adverse events can contact Medtronic at 800-448-3644 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
A version of this article appeared on Medscape.com.
Sclerosing Mesenteritis: What GIs Need to Know About This Rare Disease
AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.
Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.
“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.
The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”
As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.
No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.
“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”
Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.
Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.
The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.
Medical Therapy
Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.
Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.
Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”
Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”
In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.”
Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.
Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”
A version of this article appeared on Medscape.com.
AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.
Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.
“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.
The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”
As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.
No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.
“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”
Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.
Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.
The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.
Medical Therapy
Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.
Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.
Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”
Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”
In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.”
Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.
Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”
A version of this article appeared on Medscape.com.
AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.
Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.
“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.
The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”
As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.
No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.
“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”
Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.
Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.
The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.
Medical Therapy
Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.
Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.
Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”
Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”
In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.”
Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.
Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Video Capsule Endoscopy Aids Targeted Treatment in Quiescent Crohn’s
A treat-to target (T2T) strategy based on video capsule endoscopy (VCE) identified Crohn’s disease (CD) patients in clinical remission but with small bowel inflammation, resulting in fewer clinical flares versus a treat-by-symptoms standard approach.
“A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care,” investigators led by Shomron Ben-Horin, MD, director of gastroenterology at Sheba Medical Center in Ramat-Gan, Israel.
Published in Gastroenterology, the CURE-CD (Comprehensive Individualized Proactive Therapy of Crohn’s Disease), a prospective, temporally blinded, randomized controled trial, looked at 60 adult patients with quiescent CD involving the small bowel (either L1 or L3 iof the terminal ileum and upper colon).
The researchers defined quiescent disease as corticosteroid-free clinical remission with a Crohn’s Disease Activity Index (CDAI) of <50 for the past 3 months on a stable regimen.
Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) of ≥350 were designated high risk (n = 40) and randomized to either T2T optimization (n = 20) or continuing standard care (n = 20).
T2T was optimized with repeat VCE results every 6 months. Patients with LS <350 (“low risk”) continued standard care. The primary outcome was the rate of disease exacerbation, demonstrated by a CDAI increase of >70 points and a score >150, or hospitalization/surgery, in high-risk standard care vs T2T groups at 24 months.
Treatment intensification in the high-risk group allocated to a proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20).
The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio [OR], .14; 95% confidence interval [CI], .04–.57, P = .006).
Mucosal healing was significantly more common in the T2T group when determined by a cutoff LS < 350 (OR, 4.5, 95% CI, 1.7–17.4, nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350.
Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225–900 vs 225, 135–600, respectively, P = .07).
As to safety, of 221 VCEs ingested, there was a single (.4%) temporary retention, which spontaneously resolved.
“VCE monitoring of CD was approved into government reimbursement in Israel last year, and I know several European countries are also considering the inclusion of this new indication for VCE in their payer reimbursement,” Ben-Horin told GI & Hepatology News. “Uptake in Israel is still baby-stepping. In our center it’s much more common to monitor T2T for small bowel patients, but this approach is still not widely applied.”
The authors cautioned that since the focus was the small bowel, the findings are not necessarily generalizable to patients with Crohn’s colitis.
The study was supported by the Leona M. & Harry B. Helmsley Charitable Trust, Medtronic (USA), AbbVie (Israel), and Takeda. The funders did not intervene in the design or interpretation of the study.
Ben-Horin reported advisory, consulting fees, research support, and/or stocks/options from several pharmaceutical firms. Several coauthors disclosed similar relations with private-sector companies.
As treat-to-target (T2T) strategies continue to redefine inflammatory bowel disease (IBD) care, this randomized controlled trial by Ben-Horin et al. highlights the value of proactive video capsule endoscopy (VCE) monitoring in patients with quiescent small bowel Crohn’s disease (CD).
The study demonstrated that scheduled VCE every six months, used to guide treatment adjustments, significantly reduced clinical flares over 24 months compared to symptom-based standard care. While differences in mucosal healing between groups were less pronounced, the results underscore that monitoring objective inflammation, even in asymptomatic patients, can improve clinical outcomes.
In clinical practice, symptom-driven management remains common, often due to limited access to endoscopy or patient hesitancy toward invasive procedures. VCE offers a non-invasive, well-tolerated alternative that may improve patient adherence to disease monitoring, particularly in small bowel CD. This approach addresses a significant gap in care, as nearly half of IBD patients do not undergo objective disease assessment within a year of starting biologics.
Clinicians should consider integrating VCE into individualized T2T strategies, especially in settings where endoscopic access is constrained. Furthermore, adjunctive non-invasive tools such as intestinal ultrasound (IUS) with biomarkers could further support a non-invasive, patient-centered monitoring approach. As the definition of remission evolves toward more ambitious targets like transmural healing, the integration of cross-sectional imaging modalities such as IUS into routine monitoring protocols may become essential. Aligning monitoring techniques with evolving therapeutic targets and patient preferences will be key to optimizing long-term disease control in CD.
Mariangela Allocca, MD, PhD, is head of the IBD Center at IRCCS Hospital San Raffaele, and professor of gastroenterology at Vita-Salute San Raffaele University, both in Milan, Italy. Silvio Danese, MD, PhD, is professor of gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. Both authors report consulting and/or speaking fees from multiple drug and device companies.
As treat-to-target (T2T) strategies continue to redefine inflammatory bowel disease (IBD) care, this randomized controlled trial by Ben-Horin et al. highlights the value of proactive video capsule endoscopy (VCE) monitoring in patients with quiescent small bowel Crohn’s disease (CD).
The study demonstrated that scheduled VCE every six months, used to guide treatment adjustments, significantly reduced clinical flares over 24 months compared to symptom-based standard care. While differences in mucosal healing between groups were less pronounced, the results underscore that monitoring objective inflammation, even in asymptomatic patients, can improve clinical outcomes.
In clinical practice, symptom-driven management remains common, often due to limited access to endoscopy or patient hesitancy toward invasive procedures. VCE offers a non-invasive, well-tolerated alternative that may improve patient adherence to disease monitoring, particularly in small bowel CD. This approach addresses a significant gap in care, as nearly half of IBD patients do not undergo objective disease assessment within a year of starting biologics.
Clinicians should consider integrating VCE into individualized T2T strategies, especially in settings where endoscopic access is constrained. Furthermore, adjunctive non-invasive tools such as intestinal ultrasound (IUS) with biomarkers could further support a non-invasive, patient-centered monitoring approach. As the definition of remission evolves toward more ambitious targets like transmural healing, the integration of cross-sectional imaging modalities such as IUS into routine monitoring protocols may become essential. Aligning monitoring techniques with evolving therapeutic targets and patient preferences will be key to optimizing long-term disease control in CD.
Mariangela Allocca, MD, PhD, is head of the IBD Center at IRCCS Hospital San Raffaele, and professor of gastroenterology at Vita-Salute San Raffaele University, both in Milan, Italy. Silvio Danese, MD, PhD, is professor of gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. Both authors report consulting and/or speaking fees from multiple drug and device companies.
As treat-to-target (T2T) strategies continue to redefine inflammatory bowel disease (IBD) care, this randomized controlled trial by Ben-Horin et al. highlights the value of proactive video capsule endoscopy (VCE) monitoring in patients with quiescent small bowel Crohn’s disease (CD).
The study demonstrated that scheduled VCE every six months, used to guide treatment adjustments, significantly reduced clinical flares over 24 months compared to symptom-based standard care. While differences in mucosal healing between groups were less pronounced, the results underscore that monitoring objective inflammation, even in asymptomatic patients, can improve clinical outcomes.
In clinical practice, symptom-driven management remains common, often due to limited access to endoscopy or patient hesitancy toward invasive procedures. VCE offers a non-invasive, well-tolerated alternative that may improve patient adherence to disease monitoring, particularly in small bowel CD. This approach addresses a significant gap in care, as nearly half of IBD patients do not undergo objective disease assessment within a year of starting biologics.
Clinicians should consider integrating VCE into individualized T2T strategies, especially in settings where endoscopic access is constrained. Furthermore, adjunctive non-invasive tools such as intestinal ultrasound (IUS) with biomarkers could further support a non-invasive, patient-centered monitoring approach. As the definition of remission evolves toward more ambitious targets like transmural healing, the integration of cross-sectional imaging modalities such as IUS into routine monitoring protocols may become essential. Aligning monitoring techniques with evolving therapeutic targets and patient preferences will be key to optimizing long-term disease control in CD.
Mariangela Allocca, MD, PhD, is head of the IBD Center at IRCCS Hospital San Raffaele, and professor of gastroenterology at Vita-Salute San Raffaele University, both in Milan, Italy. Silvio Danese, MD, PhD, is professor of gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. Both authors report consulting and/or speaking fees from multiple drug and device companies.
A treat-to target (T2T) strategy based on video capsule endoscopy (VCE) identified Crohn’s disease (CD) patients in clinical remission but with small bowel inflammation, resulting in fewer clinical flares versus a treat-by-symptoms standard approach.
“A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care,” investigators led by Shomron Ben-Horin, MD, director of gastroenterology at Sheba Medical Center in Ramat-Gan, Israel.
Published in Gastroenterology, the CURE-CD (Comprehensive Individualized Proactive Therapy of Crohn’s Disease), a prospective, temporally blinded, randomized controled trial, looked at 60 adult patients with quiescent CD involving the small bowel (either L1 or L3 iof the terminal ileum and upper colon).
The researchers defined quiescent disease as corticosteroid-free clinical remission with a Crohn’s Disease Activity Index (CDAI) of <50 for the past 3 months on a stable regimen.
Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) of ≥350 were designated high risk (n = 40) and randomized to either T2T optimization (n = 20) or continuing standard care (n = 20).
T2T was optimized with repeat VCE results every 6 months. Patients with LS <350 (“low risk”) continued standard care. The primary outcome was the rate of disease exacerbation, demonstrated by a CDAI increase of >70 points and a score >150, or hospitalization/surgery, in high-risk standard care vs T2T groups at 24 months.
Treatment intensification in the high-risk group allocated to a proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20).
The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio [OR], .14; 95% confidence interval [CI], .04–.57, P = .006).
Mucosal healing was significantly more common in the T2T group when determined by a cutoff LS < 350 (OR, 4.5, 95% CI, 1.7–17.4, nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350.
Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225–900 vs 225, 135–600, respectively, P = .07).
As to safety, of 221 VCEs ingested, there was a single (.4%) temporary retention, which spontaneously resolved.
“VCE monitoring of CD was approved into government reimbursement in Israel last year, and I know several European countries are also considering the inclusion of this new indication for VCE in their payer reimbursement,” Ben-Horin told GI & Hepatology News. “Uptake in Israel is still baby-stepping. In our center it’s much more common to monitor T2T for small bowel patients, but this approach is still not widely applied.”
The authors cautioned that since the focus was the small bowel, the findings are not necessarily generalizable to patients with Crohn’s colitis.
The study was supported by the Leona M. & Harry B. Helmsley Charitable Trust, Medtronic (USA), AbbVie (Israel), and Takeda. The funders did not intervene in the design or interpretation of the study.
Ben-Horin reported advisory, consulting fees, research support, and/or stocks/options from several pharmaceutical firms. Several coauthors disclosed similar relations with private-sector companies.
A treat-to target (T2T) strategy based on video capsule endoscopy (VCE) identified Crohn’s disease (CD) patients in clinical remission but with small bowel inflammation, resulting in fewer clinical flares versus a treat-by-symptoms standard approach.
“A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care,” investigators led by Shomron Ben-Horin, MD, director of gastroenterology at Sheba Medical Center in Ramat-Gan, Israel.
Published in Gastroenterology, the CURE-CD (Comprehensive Individualized Proactive Therapy of Crohn’s Disease), a prospective, temporally blinded, randomized controled trial, looked at 60 adult patients with quiescent CD involving the small bowel (either L1 or L3 iof the terminal ileum and upper colon).
The researchers defined quiescent disease as corticosteroid-free clinical remission with a Crohn’s Disease Activity Index (CDAI) of <50 for the past 3 months on a stable regimen.
Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) of ≥350 were designated high risk (n = 40) and randomized to either T2T optimization (n = 20) or continuing standard care (n = 20).
T2T was optimized with repeat VCE results every 6 months. Patients with LS <350 (“low risk”) continued standard care. The primary outcome was the rate of disease exacerbation, demonstrated by a CDAI increase of >70 points and a score >150, or hospitalization/surgery, in high-risk standard care vs T2T groups at 24 months.
Treatment intensification in the high-risk group allocated to a proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20).
The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio [OR], .14; 95% confidence interval [CI], .04–.57, P = .006).
Mucosal healing was significantly more common in the T2T group when determined by a cutoff LS < 350 (OR, 4.5, 95% CI, 1.7–17.4, nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350.
Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225–900 vs 225, 135–600, respectively, P = .07).
As to safety, of 221 VCEs ingested, there was a single (.4%) temporary retention, which spontaneously resolved.
“VCE monitoring of CD was approved into government reimbursement in Israel last year, and I know several European countries are also considering the inclusion of this new indication for VCE in their payer reimbursement,” Ben-Horin told GI & Hepatology News. “Uptake in Israel is still baby-stepping. In our center it’s much more common to monitor T2T for small bowel patients, but this approach is still not widely applied.”
The authors cautioned that since the focus was the small bowel, the findings are not necessarily generalizable to patients with Crohn’s colitis.
The study was supported by the Leona M. & Harry B. Helmsley Charitable Trust, Medtronic (USA), AbbVie (Israel), and Takeda. The funders did not intervene in the design or interpretation of the study.
Ben-Horin reported advisory, consulting fees, research support, and/or stocks/options from several pharmaceutical firms. Several coauthors disclosed similar relations with private-sector companies.
FROM GASTROENTEROLOGY
MASH Driving Global Epidemic of Primary Liver Cancer
Although the incidence of PLC from most etiologies is declining, MASH and alcohol-related liver disease (ALD) are exceptions.
A recent analysis in Clinical Gastroenterology and Hepatology found a near doubling of cases in from 2000 to 2021 in data from the 2024 Global Burden of Disease study.
The analysis assessed age-standardized incidence, mortality, and disability-adjusted life years (DALYs) from MASH-associated PLC, stratified by geographical region, sociodemographic index, age, and sex.
The burden of MASH-associated primary liver cancer (PLC) is rising rapidly while, thanks to effective suppressive treatments, the incidence of PLC from viral hepatitis is declining.
“Given the shifting epidemiology and limited global data, this analysis was timely to provide updated, comprehensive estimates using the GBD 2021 database,” lead authors Ju Dong Yang, MD, MS, and Karn Wijarnpreecha, MD, MPH, told GI & Hepatology News in a joint email. Yang is an associate professor and medical director of the Liver Cancer Program at Cedars-Sinai Medical Center in Los Angeles, and Wijarnpreecha is a transplant hepatologist in the of Division of Gastroenterology at University of Arizona College of Medicine in Phoenix. “Our study helps identify regions, populations, and sex-specific trends that are most affected and informs global policy response.”
Interestingly,the United States ranks among the top three countries worldwide in terms of MASH-associated PLC burden, with nearly 3,400 newly diagnosed cases reported in 2021 alone. The Americas in general experienced the highest percentage increase in age-standardized incidence rate (APC, 2.09%, 95% CI, 2.02–2.16), age-standardized death rate (APC, 1.96%; 95% CI, 1.69–2.23), and age-standardized DALYs (APC, 1.96%; 95% CI, 1.63–2.30) from MASH-associated PLC.
Globally, there were 42,290 incident cases, 40,920 deaths, and 995,470 DALYs from PLC. Global incidence (+98%), death (+93%), and DALYs (+76%) from MASH-associated PLC increased steeply over the study period.
Among different etiologies, the global study found that only MASH-associated PLC had increased mortality rates, for an annual percent change of +0.46 (95% confidence interval [CI], .33%–.59%). Africa and low-sociodemographic index countries exhibited the highest age-standardized incidence, death, and DALYs from MASH-associated PLC.
MASH promotes PLC through chronic liver inflammation, oxidative stress, lipotoxicity, and fibrosis, which together create a procarcinogenic environment even in the absence of cirrhosis. “This distinct pathway makes MASH-associated PLC harder to detect early, especially when cirrhosis is not yet evident,” Yang and Wijarnpreecha said.
By gender, DALYs increased in females (APC, .24%, 95% CI, .06–.42) but remained stable in males. “Males have higher absolute rates of MASH-associated PLC in terms of incidence and DALYs. However, our study found that the rate of increase in MASH-associated PLC-related disability is steeper in females. This suggests a growing burden among women, possibly related to aging, hormonal changes, and cumulative metabolic risk,” the authors said. In terms of age, “while our study did not assess age at onset, separate analyses have shown that both MASH-associated and alcohol-associated liver cancer are rising among younger individuals.”
Yang and Wijarnpreecha emphasized the need for a multi-pronged remedial strategy, including broad public health policies targeting obesity and metabolic syndrome and better risk stratification tools such as no-invasive biomarkers and genetic profiling. They called for investment in liver cancer surveillance, especially in populations at risk, and special attention to sex disparities and health equity across regions.
“We’re entering a new era of liver cancer epidemiology, where MASLD is taking center stage. Clinicians must recognize that MASH can progress to liver cancer even without cirrhosis,” they said. “Early diagnosis and metabolic intervention may be the best tools to curb this trend, and sex-based approaches to risk stratification and treatment may be essential moving forward.”
Yang’s research is supported by the National Institutes of Health. He consults for AstraZeneca, Eisai, Exact Sciences, and FujiFilm Medical Sciences.
Reviewing this study for GI & Hepatology News, but not involved in it, Scott L. Friedman, MD, AGAF, chief emeritus of the Division of Liver Diseases at Mount Sinai Health System in New York City and director of the newly established multidisciplinary Mount Sinai Institute for Liver Research, said the increase in primary liver cancer burden revealed by the research has been recognized for several years, especially among liver specialists, and is worsening, particularly in America.
“This is most evident in the changing composition of liver transplant waiting lists, which include a diminishing number of patients with chronic viral hepatitis, and a growing fraction of patients with steatotic liver disease, either from MASH alone or with concurrent alcohol-associated liver disease,” Friedman said. He noted that apart from the brain, the liver is the body’s least understood organ.
Friedman said that an urgent need exists for increased awareness of and screening for steatotic liver disease in primary care and general medicine practices – especially in patients with type 2 diabetes, about 70% of whom typically have steatosis – as well as those with features of the metabolic syndrome, with obesity, type 2 diabetes, lipid abnormalities and hypertension. “Awareness of metabolic-associated liver disease and MASH among patients and providers is still inadequate,” he said. “However, now that there’s a newly approved drug, Rezdiffra [resmetirom] – and more likely in the coming years – early detection and treatment of MASH will become essential to prevent its progression to cirrhosis and PLC through specific medications.”
Once patients with MASH have more advanced fibrosis, Friedman noted, regular screening for PLC is essential to detect early cancers that are still curable either by liver resection, liver transplant, or direct ablation of small tumors. “Unfortunately, it is not unusual for patients to present with an incurable PLC without realizing they had any underlying liver disease, since MASH is not associated with specific liver symptoms.”
Friedman disclosed no competing interests relevant to his comments.
Reviewing this study for GI & Hepatology News, but not involved in it, Scott L. Friedman, MD, AGAF, chief emeritus of the Division of Liver Diseases at Mount Sinai Health System in New York City and director of the newly established multidisciplinary Mount Sinai Institute for Liver Research, said the increase in primary liver cancer burden revealed by the research has been recognized for several years, especially among liver specialists, and is worsening, particularly in America.
“This is most evident in the changing composition of liver transplant waiting lists, which include a diminishing number of patients with chronic viral hepatitis, and a growing fraction of patients with steatotic liver disease, either from MASH alone or with concurrent alcohol-associated liver disease,” Friedman said. He noted that apart from the brain, the liver is the body’s least understood organ.
Friedman said that an urgent need exists for increased awareness of and screening for steatotic liver disease in primary care and general medicine practices – especially in patients with type 2 diabetes, about 70% of whom typically have steatosis – as well as those with features of the metabolic syndrome, with obesity, type 2 diabetes, lipid abnormalities and hypertension. “Awareness of metabolic-associated liver disease and MASH among patients and providers is still inadequate,” he said. “However, now that there’s a newly approved drug, Rezdiffra [resmetirom] – and more likely in the coming years – early detection and treatment of MASH will become essential to prevent its progression to cirrhosis and PLC through specific medications.”
Once patients with MASH have more advanced fibrosis, Friedman noted, regular screening for PLC is essential to detect early cancers that are still curable either by liver resection, liver transplant, or direct ablation of small tumors. “Unfortunately, it is not unusual for patients to present with an incurable PLC without realizing they had any underlying liver disease, since MASH is not associated with specific liver symptoms.”
Friedman disclosed no competing interests relevant to his comments.
Reviewing this study for GI & Hepatology News, but not involved in it, Scott L. Friedman, MD, AGAF, chief emeritus of the Division of Liver Diseases at Mount Sinai Health System in New York City and director of the newly established multidisciplinary Mount Sinai Institute for Liver Research, said the increase in primary liver cancer burden revealed by the research has been recognized for several years, especially among liver specialists, and is worsening, particularly in America.
“This is most evident in the changing composition of liver transplant waiting lists, which include a diminishing number of patients with chronic viral hepatitis, and a growing fraction of patients with steatotic liver disease, either from MASH alone or with concurrent alcohol-associated liver disease,” Friedman said. He noted that apart from the brain, the liver is the body’s least understood organ.
Friedman said that an urgent need exists for increased awareness of and screening for steatotic liver disease in primary care and general medicine practices – especially in patients with type 2 diabetes, about 70% of whom typically have steatosis – as well as those with features of the metabolic syndrome, with obesity, type 2 diabetes, lipid abnormalities and hypertension. “Awareness of metabolic-associated liver disease and MASH among patients and providers is still inadequate,” he said. “However, now that there’s a newly approved drug, Rezdiffra [resmetirom] – and more likely in the coming years – early detection and treatment of MASH will become essential to prevent its progression to cirrhosis and PLC through specific medications.”
Once patients with MASH have more advanced fibrosis, Friedman noted, regular screening for PLC is essential to detect early cancers that are still curable either by liver resection, liver transplant, or direct ablation of small tumors. “Unfortunately, it is not unusual for patients to present with an incurable PLC without realizing they had any underlying liver disease, since MASH is not associated with specific liver symptoms.”
Friedman disclosed no competing interests relevant to his comments.
Although the incidence of PLC from most etiologies is declining, MASH and alcohol-related liver disease (ALD) are exceptions.
A recent analysis in Clinical Gastroenterology and Hepatology found a near doubling of cases in from 2000 to 2021 in data from the 2024 Global Burden of Disease study.
The analysis assessed age-standardized incidence, mortality, and disability-adjusted life years (DALYs) from MASH-associated PLC, stratified by geographical region, sociodemographic index, age, and sex.
The burden of MASH-associated primary liver cancer (PLC) is rising rapidly while, thanks to effective suppressive treatments, the incidence of PLC from viral hepatitis is declining.
“Given the shifting epidemiology and limited global data, this analysis was timely to provide updated, comprehensive estimates using the GBD 2021 database,” lead authors Ju Dong Yang, MD, MS, and Karn Wijarnpreecha, MD, MPH, told GI & Hepatology News in a joint email. Yang is an associate professor and medical director of the Liver Cancer Program at Cedars-Sinai Medical Center in Los Angeles, and Wijarnpreecha is a transplant hepatologist in the of Division of Gastroenterology at University of Arizona College of Medicine in Phoenix. “Our study helps identify regions, populations, and sex-specific trends that are most affected and informs global policy response.”
Interestingly,the United States ranks among the top three countries worldwide in terms of MASH-associated PLC burden, with nearly 3,400 newly diagnosed cases reported in 2021 alone. The Americas in general experienced the highest percentage increase in age-standardized incidence rate (APC, 2.09%, 95% CI, 2.02–2.16), age-standardized death rate (APC, 1.96%; 95% CI, 1.69–2.23), and age-standardized DALYs (APC, 1.96%; 95% CI, 1.63–2.30) from MASH-associated PLC.
Globally, there were 42,290 incident cases, 40,920 deaths, and 995,470 DALYs from PLC. Global incidence (+98%), death (+93%), and DALYs (+76%) from MASH-associated PLC increased steeply over the study period.
Among different etiologies, the global study found that only MASH-associated PLC had increased mortality rates, for an annual percent change of +0.46 (95% confidence interval [CI], .33%–.59%). Africa and low-sociodemographic index countries exhibited the highest age-standardized incidence, death, and DALYs from MASH-associated PLC.
MASH promotes PLC through chronic liver inflammation, oxidative stress, lipotoxicity, and fibrosis, which together create a procarcinogenic environment even in the absence of cirrhosis. “This distinct pathway makes MASH-associated PLC harder to detect early, especially when cirrhosis is not yet evident,” Yang and Wijarnpreecha said.
By gender, DALYs increased in females (APC, .24%, 95% CI, .06–.42) but remained stable in males. “Males have higher absolute rates of MASH-associated PLC in terms of incidence and DALYs. However, our study found that the rate of increase in MASH-associated PLC-related disability is steeper in females. This suggests a growing burden among women, possibly related to aging, hormonal changes, and cumulative metabolic risk,” the authors said. In terms of age, “while our study did not assess age at onset, separate analyses have shown that both MASH-associated and alcohol-associated liver cancer are rising among younger individuals.”
Yang and Wijarnpreecha emphasized the need for a multi-pronged remedial strategy, including broad public health policies targeting obesity and metabolic syndrome and better risk stratification tools such as no-invasive biomarkers and genetic profiling. They called for investment in liver cancer surveillance, especially in populations at risk, and special attention to sex disparities and health equity across regions.
“We’re entering a new era of liver cancer epidemiology, where MASLD is taking center stage. Clinicians must recognize that MASH can progress to liver cancer even without cirrhosis,” they said. “Early diagnosis and metabolic intervention may be the best tools to curb this trend, and sex-based approaches to risk stratification and treatment may be essential moving forward.”
Yang’s research is supported by the National Institutes of Health. He consults for AstraZeneca, Eisai, Exact Sciences, and FujiFilm Medical Sciences.
Although the incidence of PLC from most etiologies is declining, MASH and alcohol-related liver disease (ALD) are exceptions.
A recent analysis in Clinical Gastroenterology and Hepatology found a near doubling of cases in from 2000 to 2021 in data from the 2024 Global Burden of Disease study.
The analysis assessed age-standardized incidence, mortality, and disability-adjusted life years (DALYs) from MASH-associated PLC, stratified by geographical region, sociodemographic index, age, and sex.
The burden of MASH-associated primary liver cancer (PLC) is rising rapidly while, thanks to effective suppressive treatments, the incidence of PLC from viral hepatitis is declining.
“Given the shifting epidemiology and limited global data, this analysis was timely to provide updated, comprehensive estimates using the GBD 2021 database,” lead authors Ju Dong Yang, MD, MS, and Karn Wijarnpreecha, MD, MPH, told GI & Hepatology News in a joint email. Yang is an associate professor and medical director of the Liver Cancer Program at Cedars-Sinai Medical Center in Los Angeles, and Wijarnpreecha is a transplant hepatologist in the of Division of Gastroenterology at University of Arizona College of Medicine in Phoenix. “Our study helps identify regions, populations, and sex-specific trends that are most affected and informs global policy response.”
Interestingly,the United States ranks among the top three countries worldwide in terms of MASH-associated PLC burden, with nearly 3,400 newly diagnosed cases reported in 2021 alone. The Americas in general experienced the highest percentage increase in age-standardized incidence rate (APC, 2.09%, 95% CI, 2.02–2.16), age-standardized death rate (APC, 1.96%; 95% CI, 1.69–2.23), and age-standardized DALYs (APC, 1.96%; 95% CI, 1.63–2.30) from MASH-associated PLC.
Globally, there were 42,290 incident cases, 40,920 deaths, and 995,470 DALYs from PLC. Global incidence (+98%), death (+93%), and DALYs (+76%) from MASH-associated PLC increased steeply over the study period.
Among different etiologies, the global study found that only MASH-associated PLC had increased mortality rates, for an annual percent change of +0.46 (95% confidence interval [CI], .33%–.59%). Africa and low-sociodemographic index countries exhibited the highest age-standardized incidence, death, and DALYs from MASH-associated PLC.
MASH promotes PLC through chronic liver inflammation, oxidative stress, lipotoxicity, and fibrosis, which together create a procarcinogenic environment even in the absence of cirrhosis. “This distinct pathway makes MASH-associated PLC harder to detect early, especially when cirrhosis is not yet evident,” Yang and Wijarnpreecha said.
By gender, DALYs increased in females (APC, .24%, 95% CI, .06–.42) but remained stable in males. “Males have higher absolute rates of MASH-associated PLC in terms of incidence and DALYs. However, our study found that the rate of increase in MASH-associated PLC-related disability is steeper in females. This suggests a growing burden among women, possibly related to aging, hormonal changes, and cumulative metabolic risk,” the authors said. In terms of age, “while our study did not assess age at onset, separate analyses have shown that both MASH-associated and alcohol-associated liver cancer are rising among younger individuals.”
Yang and Wijarnpreecha emphasized the need for a multi-pronged remedial strategy, including broad public health policies targeting obesity and metabolic syndrome and better risk stratification tools such as no-invasive biomarkers and genetic profiling. They called for investment in liver cancer surveillance, especially in populations at risk, and special attention to sex disparities and health equity across regions.
“We’re entering a new era of liver cancer epidemiology, where MASLD is taking center stage. Clinicians must recognize that MASH can progress to liver cancer even without cirrhosis,” they said. “Early diagnosis and metabolic intervention may be the best tools to curb this trend, and sex-based approaches to risk stratification and treatment may be essential moving forward.”
Yang’s research is supported by the National Institutes of Health. He consults for AstraZeneca, Eisai, Exact Sciences, and FujiFilm Medical Sciences.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Less Invasive Screening May Identify Barrett’s Esophagus Earlier
A new combination modality demonstrated excellent sensitivity and negative predictive value compared with endoscopy in a prospective study of at-risk veterans screened for Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC), a small comparative study in US veterans found.
BE is up to three times more prevalent in veterans than in the general population.
This and other minimally invasive approaches may reduce patient anxiety and increase screening rates, according to investigators led by Katarina B. Greer, MD, MS, of the VA Northeast Ohio Healthcare System and Case Western University in Cleveland. Such screening platforms are expected to open a window on improved prognosis for EAC by offering well-tolerated, office-based testing, the authors wrote in The American Journal of Gastroenterology.
Greer and colleagues compared standard upper endoscopy with EsoCheck (EC), a nonendoscopic esophageal balloon cell-sampling device coupled with EsoGuard (EG), a DNA-based precancer screening assay, with standard upper endoscopy, an FDA-approved minimally invasive alternative.
Sensitivity and specificity of combined EC/EG for esophagogastroduodenoscopy (EGD)-detected BE/EAC were 92.9% (95% CI, 66.1-99.8) and 72.2% (95% CI, 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI, 18.6-49.1) and 98.6% (95% CI, 92.4-100), respectively.
“With its strong negative predictive power, this screening modality could be a first-line tool available to a greater number of patients,” Greer and associates wrote. “Data from this test support the notion that EC could be performed as a triaging test to increase the yield of diagnostic upper endoscopy 2.5-fold.”
The US rates of EAC have increased more than six-fold in the past four decades and continue to rise. In 2023, 21,560 cases of EAC were diagnosed here. The prognosis for EAC is still poor, with fewer than 22% of patients surviving beyond 5 years.
Current guidelines recommend sedated EGD for patients with chronic gastroesophageal reflux disease (GERD) and additional BE risk factors such as smoking, obesity, and family history. This strategy, however, often fails to detect BE when symptoms are well controlled with over-the-counter or physician-prescribed therapies, Greer and colleagues noted. It also fails to detect BE in individuals without GERD, who comprise 40% of those who develop EAC.
Fewer than 5% of EACs are diagnosed as early-stage lesions caught by surveillance of patients with previously detected BE.
Study Details
The researchers recruited veterans meeting American College of Gastroenterology criteria for endoscopic BE and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center.
Of 782 eligible veterans, 130 (16.6%) entered the study and 124 completed screening. Common reasons for nonparticipation included completion of upper endoscopy outside of the VA healthcare system, lack of interest in joining a research study, and no recommendation for screening from referring gastroenterology or primary care providers. Eligible candidates had gastroesophageal reflux disorder plus three additional risk factors, such as smoking, higher BMI, male sex, age 50 years or older, and family history. The mean number of risk factors was 4.1.
“Available data suggest that family history is the strongest predictor of BE diagnosis, as prevalence of BE among those with family history was 23%,” Greer’s group wrote. “This points to high priority of pursuing screening in patients with family history of the condition, followed by patients who share multiple risk factors.”
All participants completed unsedated EC-guided distal esophageal sampling followed by a sedated EGD on the same day. The prevalence of BE/EAC was 12.9% (n = 14/2), based on standard EGD.
“The study was not powered to prospectively determine EC diagnostic accuracy for subgroups of nondysplastic and dysplastic BE and EAC. These data are reported for this device in development studies but not available for our study population,” the authors wrote. In comparison, they noted, the Cytosponge-TFF3, another nonendoscopic screening device for EAC and BE, exhibited lower sensitivity of 79.5%-87.2%, depending on lesion length, but higher specificity of 92.4%.
Procedural Anxiety
Baseline scores on the short-form six-item Spielberger State-Trait Anxiety Inventory-6 (STAI-6) revealed notable levels of periprocedural anxiety. STAI-6 scores range from 20 to 80, with higher scores indicating more severe anxiety. In the VA study, scores ranged from 20 to 60, and most domains constituting the scores were the same before and after the procedure. Participants did, however, report a statistically significant decrease in sense of worry after EC and reported good tolerability for both EC and EG.
Offering an outsider’s perspective on the study, Joshua Sloan, DO, an esophageal gastroenterologist at University of Minnesota Medical Center in Minneapolis, said that with the acceleration of US rates of EAC, developing a nonendoscopic screening tool to improve identification of Barrett’s and perhaps early EAC is important. “The study by Greer et al helps support the use of nonendoscopic screening with EsoCheck and EsoGuard to identify these conditions,” he told this news organization. “It will be interesting to see similar studies in the non-VA population as well. As the study notes, veterans are an enriched population with a higher prevalence of Barrett’s esophagus.”
Ultimately, Sloan added, “the hope is to increase our ability to identify and manage BE before it becomes EAC. Nonendoscopic screening tools have the potential to increase diagnosis and funnel the appropriate patients for endoscopic surveillance.”
The Bottom Line
“Calculations regarding effectiveness of the two-step screening strategy afforded by EC indicate that the burden of screening would be reduced by at least half (53%),” the authors wrote. Since the estimated size of the US screen-eligible population ranges from 19.7 million to 120.1 million, noninvasive tools could significantly decrease EGD procedures. A formal cost effectiveness analysis is being conducted and will be published separately.
This study was funded by a Department of Defense award.
Co-Author Chak reported device patents assigned to Case Western Reserve University and licensed to Lucid Diagnostics. The other authors had no competing interests to declare. Sloan disclosed speaking and/or advisory work for Sanofi-Regeneron, Phathom Pharmaceuticals, and Takeda Pharmaceuticals unrelated to his comments.
A version of this article first appeared on Medscape.com.
A new combination modality demonstrated excellent sensitivity and negative predictive value compared with endoscopy in a prospective study of at-risk veterans screened for Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC), a small comparative study in US veterans found.
BE is up to three times more prevalent in veterans than in the general population.
This and other minimally invasive approaches may reduce patient anxiety and increase screening rates, according to investigators led by Katarina B. Greer, MD, MS, of the VA Northeast Ohio Healthcare System and Case Western University in Cleveland. Such screening platforms are expected to open a window on improved prognosis for EAC by offering well-tolerated, office-based testing, the authors wrote in The American Journal of Gastroenterology.
Greer and colleagues compared standard upper endoscopy with EsoCheck (EC), a nonendoscopic esophageal balloon cell-sampling device coupled with EsoGuard (EG), a DNA-based precancer screening assay, with standard upper endoscopy, an FDA-approved minimally invasive alternative.
Sensitivity and specificity of combined EC/EG for esophagogastroduodenoscopy (EGD)-detected BE/EAC were 92.9% (95% CI, 66.1-99.8) and 72.2% (95% CI, 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI, 18.6-49.1) and 98.6% (95% CI, 92.4-100), respectively.
“With its strong negative predictive power, this screening modality could be a first-line tool available to a greater number of patients,” Greer and associates wrote. “Data from this test support the notion that EC could be performed as a triaging test to increase the yield of diagnostic upper endoscopy 2.5-fold.”
The US rates of EAC have increased more than six-fold in the past four decades and continue to rise. In 2023, 21,560 cases of EAC were diagnosed here. The prognosis for EAC is still poor, with fewer than 22% of patients surviving beyond 5 years.
Current guidelines recommend sedated EGD for patients with chronic gastroesophageal reflux disease (GERD) and additional BE risk factors such as smoking, obesity, and family history. This strategy, however, often fails to detect BE when symptoms are well controlled with over-the-counter or physician-prescribed therapies, Greer and colleagues noted. It also fails to detect BE in individuals without GERD, who comprise 40% of those who develop EAC.
Fewer than 5% of EACs are diagnosed as early-stage lesions caught by surveillance of patients with previously detected BE.
Study Details
The researchers recruited veterans meeting American College of Gastroenterology criteria for endoscopic BE and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center.
Of 782 eligible veterans, 130 (16.6%) entered the study and 124 completed screening. Common reasons for nonparticipation included completion of upper endoscopy outside of the VA healthcare system, lack of interest in joining a research study, and no recommendation for screening from referring gastroenterology or primary care providers. Eligible candidates had gastroesophageal reflux disorder plus three additional risk factors, such as smoking, higher BMI, male sex, age 50 years or older, and family history. The mean number of risk factors was 4.1.
“Available data suggest that family history is the strongest predictor of BE diagnosis, as prevalence of BE among those with family history was 23%,” Greer’s group wrote. “This points to high priority of pursuing screening in patients with family history of the condition, followed by patients who share multiple risk factors.”
All participants completed unsedated EC-guided distal esophageal sampling followed by a sedated EGD on the same day. The prevalence of BE/EAC was 12.9% (n = 14/2), based on standard EGD.
“The study was not powered to prospectively determine EC diagnostic accuracy for subgroups of nondysplastic and dysplastic BE and EAC. These data are reported for this device in development studies but not available for our study population,” the authors wrote. In comparison, they noted, the Cytosponge-TFF3, another nonendoscopic screening device for EAC and BE, exhibited lower sensitivity of 79.5%-87.2%, depending on lesion length, but higher specificity of 92.4%.
Procedural Anxiety
Baseline scores on the short-form six-item Spielberger State-Trait Anxiety Inventory-6 (STAI-6) revealed notable levels of periprocedural anxiety. STAI-6 scores range from 20 to 80, with higher scores indicating more severe anxiety. In the VA study, scores ranged from 20 to 60, and most domains constituting the scores were the same before and after the procedure. Participants did, however, report a statistically significant decrease in sense of worry after EC and reported good tolerability for both EC and EG.
Offering an outsider’s perspective on the study, Joshua Sloan, DO, an esophageal gastroenterologist at University of Minnesota Medical Center in Minneapolis, said that with the acceleration of US rates of EAC, developing a nonendoscopic screening tool to improve identification of Barrett’s and perhaps early EAC is important. “The study by Greer et al helps support the use of nonendoscopic screening with EsoCheck and EsoGuard to identify these conditions,” he told this news organization. “It will be interesting to see similar studies in the non-VA population as well. As the study notes, veterans are an enriched population with a higher prevalence of Barrett’s esophagus.”
Ultimately, Sloan added, “the hope is to increase our ability to identify and manage BE before it becomes EAC. Nonendoscopic screening tools have the potential to increase diagnosis and funnel the appropriate patients for endoscopic surveillance.”
The Bottom Line
“Calculations regarding effectiveness of the two-step screening strategy afforded by EC indicate that the burden of screening would be reduced by at least half (53%),” the authors wrote. Since the estimated size of the US screen-eligible population ranges from 19.7 million to 120.1 million, noninvasive tools could significantly decrease EGD procedures. A formal cost effectiveness analysis is being conducted and will be published separately.
This study was funded by a Department of Defense award.
Co-Author Chak reported device patents assigned to Case Western Reserve University and licensed to Lucid Diagnostics. The other authors had no competing interests to declare. Sloan disclosed speaking and/or advisory work for Sanofi-Regeneron, Phathom Pharmaceuticals, and Takeda Pharmaceuticals unrelated to his comments.
A version of this article first appeared on Medscape.com.
A new combination modality demonstrated excellent sensitivity and negative predictive value compared with endoscopy in a prospective study of at-risk veterans screened for Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC), a small comparative study in US veterans found.
BE is up to three times more prevalent in veterans than in the general population.
This and other minimally invasive approaches may reduce patient anxiety and increase screening rates, according to investigators led by Katarina B. Greer, MD, MS, of the VA Northeast Ohio Healthcare System and Case Western University in Cleveland. Such screening platforms are expected to open a window on improved prognosis for EAC by offering well-tolerated, office-based testing, the authors wrote in The American Journal of Gastroenterology.
Greer and colleagues compared standard upper endoscopy with EsoCheck (EC), a nonendoscopic esophageal balloon cell-sampling device coupled with EsoGuard (EG), a DNA-based precancer screening assay, with standard upper endoscopy, an FDA-approved minimally invasive alternative.
Sensitivity and specificity of combined EC/EG for esophagogastroduodenoscopy (EGD)-detected BE/EAC were 92.9% (95% CI, 66.1-99.8) and 72.2% (95% CI, 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI, 18.6-49.1) and 98.6% (95% CI, 92.4-100), respectively.
“With its strong negative predictive power, this screening modality could be a first-line tool available to a greater number of patients,” Greer and associates wrote. “Data from this test support the notion that EC could be performed as a triaging test to increase the yield of diagnostic upper endoscopy 2.5-fold.”
The US rates of EAC have increased more than six-fold in the past four decades and continue to rise. In 2023, 21,560 cases of EAC were diagnosed here. The prognosis for EAC is still poor, with fewer than 22% of patients surviving beyond 5 years.
Current guidelines recommend sedated EGD for patients with chronic gastroesophageal reflux disease (GERD) and additional BE risk factors such as smoking, obesity, and family history. This strategy, however, often fails to detect BE when symptoms are well controlled with over-the-counter or physician-prescribed therapies, Greer and colleagues noted. It also fails to detect BE in individuals without GERD, who comprise 40% of those who develop EAC.
Fewer than 5% of EACs are diagnosed as early-stage lesions caught by surveillance of patients with previously detected BE.
Study Details
The researchers recruited veterans meeting American College of Gastroenterology criteria for endoscopic BE and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center.
Of 782 eligible veterans, 130 (16.6%) entered the study and 124 completed screening. Common reasons for nonparticipation included completion of upper endoscopy outside of the VA healthcare system, lack of interest in joining a research study, and no recommendation for screening from referring gastroenterology or primary care providers. Eligible candidates had gastroesophageal reflux disorder plus three additional risk factors, such as smoking, higher BMI, male sex, age 50 years or older, and family history. The mean number of risk factors was 4.1.
“Available data suggest that family history is the strongest predictor of BE diagnosis, as prevalence of BE among those with family history was 23%,” Greer’s group wrote. “This points to high priority of pursuing screening in patients with family history of the condition, followed by patients who share multiple risk factors.”
All participants completed unsedated EC-guided distal esophageal sampling followed by a sedated EGD on the same day. The prevalence of BE/EAC was 12.9% (n = 14/2), based on standard EGD.
“The study was not powered to prospectively determine EC diagnostic accuracy for subgroups of nondysplastic and dysplastic BE and EAC. These data are reported for this device in development studies but not available for our study population,” the authors wrote. In comparison, they noted, the Cytosponge-TFF3, another nonendoscopic screening device for EAC and BE, exhibited lower sensitivity of 79.5%-87.2%, depending on lesion length, but higher specificity of 92.4%.
Procedural Anxiety
Baseline scores on the short-form six-item Spielberger State-Trait Anxiety Inventory-6 (STAI-6) revealed notable levels of periprocedural anxiety. STAI-6 scores range from 20 to 80, with higher scores indicating more severe anxiety. In the VA study, scores ranged from 20 to 60, and most domains constituting the scores were the same before and after the procedure. Participants did, however, report a statistically significant decrease in sense of worry after EC and reported good tolerability for both EC and EG.
Offering an outsider’s perspective on the study, Joshua Sloan, DO, an esophageal gastroenterologist at University of Minnesota Medical Center in Minneapolis, said that with the acceleration of US rates of EAC, developing a nonendoscopic screening tool to improve identification of Barrett’s and perhaps early EAC is important. “The study by Greer et al helps support the use of nonendoscopic screening with EsoCheck and EsoGuard to identify these conditions,” he told this news organization. “It will be interesting to see similar studies in the non-VA population as well. As the study notes, veterans are an enriched population with a higher prevalence of Barrett’s esophagus.”
Ultimately, Sloan added, “the hope is to increase our ability to identify and manage BE before it becomes EAC. Nonendoscopic screening tools have the potential to increase diagnosis and funnel the appropriate patients for endoscopic surveillance.”
The Bottom Line
“Calculations regarding effectiveness of the two-step screening strategy afforded by EC indicate that the burden of screening would be reduced by at least half (53%),” the authors wrote. Since the estimated size of the US screen-eligible population ranges from 19.7 million to 120.1 million, noninvasive tools could significantly decrease EGD procedures. A formal cost effectiveness analysis is being conducted and will be published separately.
This study was funded by a Department of Defense award.
Co-Author Chak reported device patents assigned to Case Western Reserve University and licensed to Lucid Diagnostics. The other authors had no competing interests to declare. Sloan disclosed speaking and/or advisory work for Sanofi-Regeneron, Phathom Pharmaceuticals, and Takeda Pharmaceuticals unrelated to his comments.
A version of this article first appeared on Medscape.com.
FROM AMERICAN JOURNAL OF GASTROENTEROLOGY