drugset / Trial / NCT02110810

Indomethacin Decreases Post-ERCP Pancreatitis

NCT02110810

Phase 3 Completed 160 enrolled Mexican Social Security Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis represents the most common and feared complication following ERCP. The reported incidence of this complication is from 1% to 40% according to the presence of high-risk factors for this complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients, respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or procedure-related.

Timeline

Start
2014-01
Primary completion
2015-01
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Indomethacin Small molecule 100 mg Rectal

Indications