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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis

RecruitingNAAges 18 Years - anyAllInstituto do Cancer do Estado de São Paulo
NCT07738094 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • NSAID alone
  • Cryoprevention associated with NSAID
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Where

1 site
Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil.
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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