Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis

Overview

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.

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.

Conditions