Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis

Recruiting now · Not applicable

Conditions studied: Pancreatitis, Acute

In brief

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.

Key facts

Study ID

NCT07738094

Run by

Instituto do Cancer do Estado de São Paulo

People needed

462

Starts

2026-06-09

Expected to finish

2028-08-31

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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