Importance:Pancreas divisum is implicated as an obstructive cause for acute pancreatitis. Observational data suggest endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy reduces the risk of pancreatitis episodes. Even though this endoscopic procedure is widely used in practice, clinical trials are lacking. Objective:To determine whether ERCP with minor papillotomy reduces the risk of acute pancreatitis among adults with unexplained acute recurrent pancreatitis and pancreas divisum. Design, Setting, and Participants:This multicenter, sham-controlled, double-blind randomized clinical trial enrolled adults with 2 or more episodes of acute pancreatitis and pancreas divisum. Adults with other etiologies for acute pancreatitis or concomitant chronic calcific pancreatitis were excluded. The trial was conducted between September 1, 2018, and August 30, 2024, at 21 referral centers in the US and Canada. Last follow-up occurred on February 15, 2025. Intervention:Participants were randomized in a 1:1 ratio to ERCP with minor papillotomy or sham ERCP. Main Outcomes and Measures:The primary outcome was development of acute pancreatitis more than 30 days after randomization as a time-to-event outcome. The secondary outcomes included acute pancreatitis episode frequency and development of chronic calcific pancreatitis, diabetes, and exocrine pancreatic dysfunction. Results:A total of 148 participants were randomized (mean age, 54 [SD, 19.5] years; 68.2% female; 95.3% non-Hispanic or Latino and 87.2% White; mean lifetime acute pancreatitis episodes, 3 [SD, 2]; mean duct diameter, 2.2 [SD, 1.3] mm) and followed up for a median of 34 months (IQR, 21.7-45.7 months). Of the 75 participants in the ERCP with minor papillotomy group, 26 (34.7%) developed acute pancreatitis compared with 32 of 73 participants (43.8%) in the sham ERCP group (adjusted hazard ratio, 0.83 [95% CI, 0.49 to 1.41]). The incidence rate ratio for acute recurrent pancreatitis episode frequency was 0.25 (95% CI, 0.18 to 0.34) in the ERCP with minor papillotomy group vs 0.30 (95% CI, 0.23 to 0.41) in the sham ERCP group. There were no between-group differences in frequency and incidence of chronic calcific pancreatitis (4.0% in the ERCP with minor papillotomy group vs 2.7% in the sham ERCP group; risk difference [RD], 0.01 [95% CI, -0.05 to 0.07]), diabetes (15.8% vs 12.8%, respectively; RD, 0.03 [95% CI, -0.13 to 0.19]), and exocrine pancreatic dysfunction (7.7% vs 17.2%; RD, -0.10 [95% CI, -0.27 to 0.08]). The adverse event of acute pancreatitis within 30 days of randomization occurred more frequently in the ERCP with minor papillotomy group (14.7%) vs the sham ERCP group (8.2%) (RD, 0.06 [95% CI, -0.04 to 0.17]). Conclusions and Relevance:Among patients with unexplained acute recurrent pancreatitis and pancreas divisum, ERCP with minor papillotomy does not reduce the risk of another episode of acute pancreatitis or related sequelae. Trial Registration:ClinicalTrials.gov Identifier: NCT03609944.

BACKGROUND:EUS-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for the management of gastric outlet obstruction (GOO). EUS-GE has demonstrated excellent short-term efficacy without the risks of surgical bypass. However, there is limited data on follow-up outcomes. In this study, we collected 6-month follow-up data on patients who underwent EUS-GE for benign and malignant etiologies, to aim to show the shift in paradigm in their management algorithm. METHODS:This was a retrospective multicenter study across 7 international centers of consecutive patients undergoing EUS-GE over a 4-year period who were entered in a dedicated registry. Demographic characteristics, procedure-related information, and follow-up data were collected. Primary outcome was the 6-month data on clinical resolution of GOO. RESULTS:Ninety-one patients were included (71 malignant and 20 benign cases). Technical success was 99% due to high expertise and volume. Clinical success at 48 hours was 97% (88/90) with an average procedure time of 47 minutes and length of stay of 5.86 days. At 3 months, 87 (95.6%) patients had achieved clinical resolution. At 6 months, 48 (53%) subjects were alive, 40 (44%) were deceased, 3 were lost to follow-up (3.3%) and 1 (1%) had a recurrence of GOO. Clinical success at 6 months follow-up was 98% (47/48). CONCLUSIONS:The majority of patients with GOO who undergo EUS-GE showed clinical resolution at 6-month follow-up. Patients with malignant etiology are appropriately palliated during their life span. Further prospective studies are necessary to obtain long-term data regarding EUS-GE for benign etiologies.

Background: EUS-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for the management of gastric outlet obstruction (GOO). EUS-GE has demonstrated excellent short-term efficacy without the risks of surgical bypass. However, there is limited data on follow-up outcomes. In this study, we collected 6-month follow-up data on patients who underwent EUS-GE for benign and malignant etiologies, to aim to show the shift in paradigm in their management algorithm. Methods: This was a retrospective multicenter study across 7 international centers of consecutive patients undergoing EUS-GE over a 4-year period who were entered in a dedicated registry. Demographic characteristics, procedure-related information, and follow-up data were collected. Primary outcome was the 6-month data on clinical resolution of GOO. Results: Ninety-one patients were included (71 malignant and 20 benign cases). Technical success was 99% due to high expertise and volume. Clinical success at 48 hours was 97% (88/90) with an average procedure time of 47 minutes and length of stay of 5.86 days. At 3 months, 87 (95.6%) patients had achieved clinical resolution. At 6 months, 48 (53%) subjects were alive, 40 (44%) were deceased, 3 were lost to follow-up (3.3%) and 1 (1%) had a recurrence of GOO. Clinical success at 6 months follow-up was 98% (47/48). Conclusions: The majority of patients with GOO who undergo EUS-GE showed clinical resolution at 6-month follow-up. Patients with malignant etiology are appropriately palliated during their life span. Further prospective studies are necessary to obtain long-term data regarding EUS-GE for benign etiologies.

QuestionDoes endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy reduce the risk of acute pancreatitis in patients with unexplained acute recurrent pancreatitis and pancreas divisum anatomy?FindingsIn this randomized trial including 148 individuals with unexplained acute recurrent pancreatitis and pancreas divisum followed up for a median of 34 months, ERCP with minor papillotomy did not significantly reduce the rate of acute pancreatitis during follow-up (34.7% vs 43.8% for sham ERCP; adjusted hazard ratio, 0.83 [95% CI, 0.49-1.41]). There was no between-group difference in acute pancreatitis episode frequency and development of chronic calcific pancreatitis, diabetes, or exocrine pancreatic dysfunction.MeaningAmong patients with unexplained acute recurrent pancreatitis and pancreas divisum, ERCP with minor papillotomy does not reduce the risk of another episode of acute pancreatitis or related sequelae. ImportancePancreas divisum is implicated as an obstructive cause for acute pancreatitis. Observational data suggest endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy reduces the risk of pancreatitis episodes. Even though this endoscopic procedure is widely used in practice, clinical trials are lacking.ObjectiveTo determine whether ERCP with minor papillotomy reduces the risk of acute pancreatitis among adults with unexplained acute recurrent pancreatitis and pancreas divisum.Design, Setting, and ParticipantsThis multicenter, sham-controlled, double-blind randomized clinical trial enrolled adults with 2 or more episodes of acute pancreatitis and pancreas divisum. Adults with other etiologies for acute pancreatitis or concomitant chronic calcific pancreatitis were excluded. The trial was conducted between September 1, 2018, and August 30, 2024, at 21 referral centers in the US and Canada. Last follow-up occurred on February 15, 2025.InterventionParticipants were randomized in a 1:1 ratio to ERCP with minor papillotomy or sham ERCP.Main Outcomes and MeasuresThe primary outcome was development of acute pancreatitis more than 30 days after randomization as a time-to-event outcome. The secondary outcomes included acute pancreatitis episode frequency and development of chronic calcific pancreatitis, diabetes, and exocrine pancreatic dysfunction.ResultsA total of 148 participants were randomized (mean age, 54 [SD, 19.5] years; 68.2% female; 95.3% non-Hispanic or Latino and 87.2% White; mean lifetime acute pancreatitis episodes, 3 [SD, 2]; mean duct diameter, 2.2 [SD, 1.3] mm) and followed up for a median of 34 months (IQR, 21.7-45.7 months). Of the 75 participants in the ERCP with minor papillotomy group, 26 (34.7%) developed acute pancreatitis compared with 32 of 73 participants (43.8%) in the sham ERCP group (adjusted hazard ratio, 0.83 [95% CI, 0.49 to 1.41]). The incidence rate ratio for acute recurrent pancreatitis episode frequency was 0.25 (95% CI, 0.18 to 0.34) in the ERCP with minor papillotomy group vs 0.30 (95% CI, 0.23 to 0.41) in the sham ERCP group. There were no between-group differences in frequency and incidence of chronic calcific pancreatitis (4.0% in the ERCP with minor papillotomy group vs 2.7% in the sham ERCP group; risk difference [RD], 0.01 [95% CI, -0.05 to 0.07]), diabetes (15.8% vs 12.8%, respectively; RD, 0.03 [95% CI, -0.13 to 0.19]), and exocrine pancreatic dysfunction (7.7% vs 17.2%; RD, -0.10 [95% CI, -0.27 to 0.08]). The adverse event of acute pancreatitis within 30 days of randomization occurred more frequently in the ERCP with minor papillotomy group (14.7%) vs the sham ERCP group (8.2%) (RD, 0.06 [95% CI, -0.04 to 0.17]).Conclusions and RelevanceAmong patients with unexplained acute recurrent pancreatitis and pancreas divisum, ERCP with minor papillotomy does not reduce the risk of another episode of acute pancreatitis or related sequelae.Trial RegistrationClinicalTrials.gov Identifier: NCT03609944 This randomized clinical trial compares the use of endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy vs a sham ERCP procedure for the treatment of patients with idiopathic acute pancreatitis with pancreas divisum.

Achalasia is a motility disorder of the esophagogastric junction outflow, characterized by impaired lower esophageal sphincter (LES) relaxation and loss of normal peristalsis of the esophageal smooth muscle. The common clinical manifestations of achalasia include dysphagia of both solids and liquids, regurgitation of undigested food and saliva, and chest pain. It shares symptoms with gastroesophageal reflux disease (GERD), such as a retrosternal burning sensation and dysphagia, which can delay the diagnosis. Several modalities are useful in establishing the diagnosis of achalasia, including high-resolution manometry (HRM), barium esophagram (BE), and upper endoscopy. Despite potential issues with HRM, it remains the gold standard for diagnosing achalasia, underscoring the importance of proper technique and interpretation. Improper probe placement can lead to inaccurate diagnoses. Here, we present the case of a patient with achalasia who was misdiagnosed with GERD and underwent an inappropriate Toupet fundoplication, who eventually required peroral endoscopic myotomy (POEM) as a salvage treatment to relieve their symptoms.