• B Joseph Elmunzer, Lydia D Foster, Jose Serrano, Gregory A Coté, Steven A Edmundowicz, Sachin Wani, Raj Shah, Ji Young Bang, Shyam Varadarajulu, Vikesh K Singh, Mouen Khashab, Richard S Kwon, James M Scheiman, Field F Willingham, Steven A Keilin, Georgios I Papachristou, Amitabh Chak, Adam Slivka, Daniel Mullady, Vladimir Kushnir, James Buxbaum, Rajesh Keswani, Timothy B Gardner, Nauzer Forbes, Amit Rastogi, Andrew Ross, Joanna Law, Patrick Yachimski, Yen-I Chen, Alan Barkun, Zachary L Smith, Bret Petersen, Andrew Y Wang, John R Saltzman, Rebecca L Spitzer, Collins Ordiah, Cathie Spino, Valerie Durkalski-Mauldin, and SVI Study Group.
• Division of Gastroenterology & Hepatology, Medical University of South Carolina, Charleston, SC, USA. Electronic address: elmunzer@musc.edu.
• Lancet. 2024 Feb 3; 403 (10425): 450458450-458.

BackgroundThe combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention.MethodsIn this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete.FindingsBetween Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups.InterpretationFor preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines.FundingUS National Institutes of Health.Copyright © 2024 Elsevier Ltd. All rights reserved.

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