A Randomized Controlled Trial of Rectal Indomethacin for the Prevention of Post-ERCP Pancreatitis

Methods: A multi-center, randomized, placebo-controlled, double-blinded clinical trial enrolling subjects at elevated risk for post-ERCP pancreatitis was conducted. High-risk subjects were included on the basis of validated patient and procedure-related risk factors. Enrolled subjects were randomized to receive a single dose of rectal indomethacin or placebo immediately after ERCP. The primary outcome was post-ERCP pancreatitis, defined as new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.