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A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.
N Engl J Med. 2012 Apr 12; 366(15):1414-22.NEJM

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.).

Authors+Show Affiliations

Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI 48109, USA. badihe@umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

22494121

Citation

Elmunzer, B Joseph, et al. "A Randomized Trial of Rectal Indomethacin to Prevent post-ERCP Pancreatitis." The New England Journal of Medicine, vol. 366, no. 15, 2012, pp. 1414-22.
Elmunzer BJ, Scheiman JM, Lehman GA, et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012;366(15):1414-22.
Elmunzer, B. J., Scheiman, J. M., Lehman, G. A., Chak, A., Mosler, P., Higgins, P. D., Hayward, R. A., Romagnuolo, J., Elta, G. H., Sherman, S., Waljee, A. K., Repaka, A., Atkinson, M. R., Cote, G. A., Kwon, R. S., McHenry, L., Piraka, C. R., Wamsteker, E. J., Watkins, J. L., ... Fogel, E. L. (2012). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. The New England Journal of Medicine, 366(15), 1414-22. https://doi.org/10.1056/NEJMoa1111103
Elmunzer BJ, et al. A Randomized Trial of Rectal Indomethacin to Prevent post-ERCP Pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. PubMed PMID: 22494121.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. AU - Elmunzer,B Joseph, AU - Scheiman,James M, AU - Lehman,Glen A, AU - Chak,Amitabh, AU - Mosler,Patrick, AU - Higgins,Peter D R, AU - Hayward,Rodney A, AU - Romagnuolo,Joseph, AU - Elta,Grace H, AU - Sherman,Stuart, AU - Waljee,Akbar K, AU - Repaka,Aparna, AU - Atkinson,Matthew R, AU - Cote,Gregory A, AU - Kwon,Richard S, AU - McHenry,Lee, AU - Piraka,Cyrus R, AU - Wamsteker,Erik J, AU - Watkins,James L, AU - Korsnes,Sheryl J, AU - Schmidt,Suzette E, AU - Turner,Sarah M, AU - Nicholson,Sylvia, AU - Fogel,Evan L, AU - ,, PY - 2012/4/13/entrez PY - 2012/4/13/pubmed PY - 2012/4/20/medline SP - 1414 EP - 22 JF - The New England journal of medicine JO - N Engl J Med VL - 366 IS - 15 N2 - 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.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/22494121/A_randomized_trial_of_rectal_indomethacin_to_prevent_post_ERCP_pancreatitis_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa1111103?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -