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Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Sponsor: University Hospital Virgen de las Nieves
Summary
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.
Official title: Prevention of Post-ERCP Pancreatitis With Cold Water Irrigation of the Papilla Added to Rectal NSAIDs Versus Rectal NSAIDs Alone: a Single-Center, Randomized, Single-Blind Pilot Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-11-01
Completion Date
2028-06-30
Last Updated
2026-10-21
Healthy Volunteers
No
Interventions
Cold water irrigation of the papilla
250 mL of ice-cold water (5 × 50 mL) instilled through the duodenoscope working channel after sphincterotomy; the first four aliquots are aspirated
Rectal NSAID (diclofenac 100 mg)
Standard pre-procedural prophylaxis administered to all patients
Locations (1)
Department of Gastroenterology and Hepatology. Virgen de las Nieves University Hospitals
Granada, Granada, Spain