Rectal Indomethacin for Post-ERCP Pancreatitis Prophylaxis in Average Risk Patients: Too Early to Terminate and Too Early to Conclude

We read with great interest the study by Levenick et al entitled, “Rectal Indomethacin Does not Prevent Post-ERCP Pancreatitis in Consecutive Patients.”1 The authors evaluated the efficacy of rectal indomethacin vs placebo for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in a predominately average risk population (70%) and concluded that it is ineffective for PEP prophylaxis (odds ratio [OR], 1.51; 95% CI, 0.68-3.33). We are concerned about the early termination of the trial by the Data and Safety Monitoring Board after an interim analysis suggested futility of the anticipated primary endpoint.

This entry was posted in News. Bookmark the permalink.