A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

  • Elmunzer B
  • Scheiman J
  • Lehman G
  • et al.
539Citations
Citations of this article
337Readers
Mendeley users who have this article in their library.

Abstract

BACKGROUND: Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). METHODS:In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights. RESULTS:A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P = 0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P = 0.03). CONCLUSIONS: Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.) Copyright © 2012 Massachusetts Medical Society.

Cite

CITATION STYLE

APA

Elmunzer, B. J., Scheiman, J. M., Lehman, G. A., Chak, A., Mosler, P., Higgins, P. D. R., … Fogel, E. L. (2012). A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis. New England Journal of Medicine, 366(15), 1414–1422. https://doi.org/10.1056/nejmoa1111103

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free