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Recruiting
NCT07738094
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Conditions: Pancreatitis, Acute
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 583
Sponsor: Instituto do Cancer do Estado de São Paulo
Location: Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil. São Paulo 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.
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.
Source: ClinicalTrials.gov (NCT07738094). StuddyBuddy aggregates publicly available trial information.