Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Comparison Between Local Cryoprevention Associated With NSAIDs Versus NSAIDs Alone for Reducing the Incidence of Post-ERCP Pancreatitis: a Randomized Clinical Trial
Instituto do Cancer do Estado de São Paulo
583 participants
Jun 9, 2026
INTERVENTIONAL
Conditions
Summary
The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.
Eligibility
Plain Language Summary
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Interventions
Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).
Locations(1)
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NCT07738094