Combination of Rectal Indomethacin and Cold Water Irrigation After ERCP to Reduce Post-ERCP Pancreatitis Compared to Rectal Indomethacin Alone

What this Trial Is About

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used to treat biliary and pancreatic diseases but can cause complications ranging from mild to severe, with post-ERCP pancreatitis (PEP) being the most serious and frequent. This study evaluates whether combining rectal indomethacin with cold-water irrigation of the ampulla reduces PEP more effectively than rectal indomethacin alone. The trial is a single-center pilot randomized controlled superiority trial conducted over 12 months with a 30-day follow-up, focusing on an Indian population. Participants will receive either rectal indomethacin alone or rectal indomethacin plus cold saline irrigation (4-10°C, 250 mL for 2 minutes) applied to the ampulla after ERCP. Rectal indomethacin (100 mg suppository) is administered 30-60 minutes before the ERCP procedure. The study compares the combination treatment to standard NSAID prevention methods, aiming to assess if the cooling adds benefit in reducing PEP incidence and severity. Throughout the study, participants will be monitored for PEP categorization within 10 days, with measurements of serum amylase and lipase, abdominal pain scores, and detection of adverse events like gastrointestinal bleeding, perforation, cholangitis, aspiration, and hypoxemia within 24 hours post-ERCP. Researchers will also evaluate hospital or intensive care stay length and adherence to the cooling protocol. The total participation includes the procedure and follow-up assessments for 30 days.

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