Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)

Post-ERCP pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal non-steroidal anti-inflammatory drugs (NSAIDs) are the current standard prophylaxis. Recent studies suggest that irrigating the papilla with cold water after biliary sphincterotomy may reduce the risk of pancreatitis, but this has not been tested in combination with rectal NSAIDs. This pilot randomized trial compares rectal NSAIDs plus cold water irrigation of the papilla with rectal NSAIDs alone in adults undergoing ERCP with sphincterotomy. Patients are unaware of their group. The main outcome is the incidence of post-ERCP pancreatitis. Results will be used to estimate event rates and calculate the sample size of a future confirmatory trial. Unlike previous trials, prophylaxis consists of rectal diclofenac without aggressive intravenous hydration, reflecting standard European practice.

Inclusion Criteria: * Age 18 years or older. * ERCP in a patient with a native papilla. * Biliary sphincterotomy performed during the procedure. * Rectal NSAID prophylaxis administered. * Signed informed consent. Exclusion Criteria: * Non-native papilla or surgically altered biliary anatomy (except liver transplant recipients). * Allergy or hypersensitivity to NSAIDs. * Acute or chronic pancreatitis. * Cancer of the pancreatic head. * Refusal to participate or to sign informed consent.