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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis

Sponsor: Instituto do Cancer do Estado de São Paulo • ClinicalTrials.gov ID: NCT07738094

Registry updated: 2026-08-25

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Description

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.

Interventions

NSAID alone (Procedure)
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 (Procedure)
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).

Eligibility criteria

Inclusion Criteria: * Patients aged 18 years or older * Clinical indication for ERCP * Presence of native major duodenal papilla without previous manipulation * Ability of the patient or companion to provide informed consent. Exclusion Criteria: * Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation) * Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved) * Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions) * Pregnant women * Refusal to participate in the study or inability to sign the ICF * Contraindication to NSAID use.

Conditions

Pancreatitis, Acute

Locations

Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil. — São Paulo, São Paulo, Brazil

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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