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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Sponsor: Instituto do Cancer do Estado de São Paulo
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.
Official title: Comparison Between Local Cryoprevention Associated With NSAIDs Versus NSAIDs Alone for Reducing the Incidence of Post-ERCP Pancreatitis: a Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
583
Start Date
2026-06-09
Completion Date
2028-08-31
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
NSAID alone
Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
Cryoprevention associated with NSAID
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)
Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil.
São Paulo, São Paulo, Brazil