Ice water plus NSAIDs to prevent post-ERCP pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center study compares two prophylaxis approaches for preventing post-ERCP pancreatitis. All participants receive rectal indomethacin, while the intervention group also receives a 250 mL instillation of ice-cold water around the papillary region after the procedure. It is a sequential, blinded design with 1:1 allocation, and the target sample size is about 583 to account for dropouts. The trial is conducted at a single tertiary center in São Paulo, Brazil, under standard ERCP care with IV fluids. Primary outcome is incidence of post-ERCP pancreatitis in the two groups.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Fauze Maluf Filho — Hospital das Clínicas da Universidade de São Paulo
• Study coordinator: Prof. Dr. Fauze Maluf Filho
• Email: fauze.maluf@terra.com.br
• Phone: +55 11 99191-9014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.