Comparing Rectal Indomethacin Alone Versus Combined with Cold Water Irrigation To Prevent Post-ERCP Pancreatitis in Adults

What this Trial Is About

Endoscopic retrograde cholangiopancreatography ERCP is widely used to manage biliary and pancreatic diseases, but it can lead to complications ranging from mild to severe, with post-ERCP pancreatitis PEP being the most common serious adverse event. This research aims to evaluate whether combining rectal indomethacin with cold-water irrigation of the ampulla reduces the incidence of PEP compared to rectal indomethacin alone, focusing on an Indian adult population. The study also compares PEP severity, adverse effects, hospital stay duration, and protocol adherence. Participants will receive either rectal indomethacin alone or rectal indomethacin plus cold saline irrigation 4-10C, 250 mL for 2 minutes applied before ERCP. Rectal indomethacin is administered 30 to 60 minutes prior to the procedure. This is a single-center pilot randomized control superiority trial lasting 12 months with a 30-day follow-up period. The study will explore effects based on baseline PEP risk, ERCP type, and use of prophylactic pancreatic stenting. During the study, participants will be assessed for post-ERCP pancreatitis classification within 10 days, with evaluations of serum amylase and lipase, abdominal pain scores, and adverse events such as gastrointestinal bleeding, perforation, cholangitis, aspiration, and hypoxemia within 24 hours after ERCP. The study includes monitoring for feasibility, adherence, and safety through clinical evaluations and laboratory tests. Total participation includes treatment and follow-up lasting up to 30 days after the procedure.

A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT