Comparing 100mg Rectal Indomethacin and Diclofenac to Prevent Post-ERCP Pancreatitis in Adults

What this Trial Is About

Pancreatitis is a common and serious complication following endoscopic retrograde cholangiopancreatography ERCP, leading to occasional death, longer hospital stays, and higher medical costs. Researchers are studying whether 100mg rectal indomethacin is more effective than 100mg rectal diclofenac in preventing post-ERCP pancreatitis PEP, as current guidelines recommend both drugs but do not clearly favor one. This multicenter, double-blind, randomized trial aims to provide stronger evidence on which drug better reduces PEP risk. Participants in this trial receive either 100mg rectal indomethacin or 100mg rectal diclofenac within 30 minutes before the ERCP procedure. The study is randomized and blinded to compare the preventive effects of these two drugs directly. The trial will enroll adult patients aged 18 to 90 years who are undergoing ERCP and do not have contraindications for either drug. During the study, participants are monitored for 30 days after the procedure to assess the rate of post-ERCP pancreatitis and other related complications such as bleeding, infection, perforation, and drug side effects. Researchers will evaluate the severity of pancreatitis using established criteria and track overall adverse events and mortality. This trial is expected to complete by the end of 2026, with detailed safety and outcome assessments performed throughout the follow-up period.

Indomethacin vs Diclofenac for Preventing PEP