Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients

Area of Science:

• Gastroenterology
• Clinical Trials
• Pharmacology

Background:

• Rectal indomethacin is used to prevent pancreatitis after ERCP in high-risk patients.
• Recent guidelines recommend it for all ERCP patients, including average-risk individuals.
• This study evaluated the efficacy of this broader recommendation.

Purpose of the Study:

• To determine if prophylactic rectal indomethacin prevents post-ERCP pancreatitis (PEP).
• To assess the efficacy in a mixed-risk cohort undergoing ERCP.

Main Methods:

• A prospective, double-blind, placebo-controlled randomized trial.
• 449 patients undergoing ERCP received either rectal indomethacin (100 mg) or placebo.
• Primary outcome: development of PEP, defined by pain, lipase levels, and hospitalization.

Main Results:

• No significant difference in PEP rates between indomethacin (7.2%) and placebo (4.9%) groups (P=.33).
• Complications and PEP severity were similar between groups.
• The study was stopped early due to futility.

Conclusions:

• Rectal indomethacin is not effective in preventing post-ERCP pancreatitis.
• The findings do not support current guidelines recommending its routine use in all ERCP patients.