Comparing Ice-Cold Water Irrigation Plus NSAIDs Versus NSAIDs Alone for Preventing Post-ERCP Pancreatitis

What this Trial Is About

Researchers are evaluating ways to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis PEP, a complication that can occur after an ERCP procedure. This study compares the standard use of rectal non-steroidal anti-inflammatory drugs NSAIDs alone with the combination of NSAIDs and irrigation of the periampullary region with ice-cold distilled water. The trial is randomized, single-center, and single-blind, aiming to improve prevention methods for PEP. Participants will undergo ERCP under sedation or general anesthesia with intravenous hydration using lactated Ringers solution. All patients receive rectal indomethacin 100 mg unless contraindicated. The intervention group will additionally receive 250 ml of ice-cold distilled water 4 to 5C instilled into the second part of the duodenum immediately after ERCP. The control group will receive the standard ERCP and NSAID treatment without the ice water irrigation. During the study, participants are monitored from immediately after the procedure up to 90 days to assess the incidence and severity of PEP and other complications such as cholangitis, bleeding, and perforation. Follow-up evaluations occur at 24 hours, 7 days, and up to 90 days post-procedure. Researchers collect data on these outcomes and monitor safety throughout the study period, which lasts until August 2028.

Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis