A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.
Author(s): Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA,
Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon
RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE,
Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in
Endoscopy (USCORE).
Affiliation(s): Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor,
MI 48109, USA. badihe@umich.edu
Publication date & source: 2012, N Engl J Med. , 366(15):1414-22
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.).
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