Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis

This study aims to evaluate the efficacy of instilling ice-cold distilled water (4ºC to 5ºC) into the second duodenal portion as an adjunct to the standard practice of using NSAIDs, comparing it with a group using NSAIDs only to reduce the incidence of PEP. This is a randomized, sequential, blinded, 1:1 paired clinical trial conducted at a single tertiary center. An initial sample of 530 participants was calculated; considering a 10% drop-out, the final calculation was 583 people. All patients will undergo ERCP under sedation or general anesthesia and will be hydrated intravenously with lactated Ringer's. Rectal administration of NSAIDs (indomethacin 100mg) will be performed for all patients without contraindications. In the intervention group, immediately after the end of the therapeutic ERCP, 250 ml of ice-cold distilled water (4º to 5ºC) will be injected towards the papillary region. The control group will undergo standard ERCP and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.

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.