title: A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.
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.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI 48109, USA. badihe@umich.edu
authors.forename: B Joseph
authors.initials: BJ
authors.lastname: Elmunzer
authors.forename: James M
authors.initials: JM
authors.lastname: Scheiman
authors.forename: Glen A
authors.initials: GA
authors.lastname: Lehman
authors.forename: Amitabh
authors.initials: A
authors.lastname: Chak
authors.forename: Patrick
authors.initials: P
authors.lastname: Mosler
authors.forename: Peter D R
authors.initials: PD
authors.lastname: Higgins
authors.forename: Rodney A
authors.initials: RA
authors.lastname: Hayward
authors.forename: Joseph
authors.initials: J
authors.lastname: Romagnuolo
authors.forename: Grace H
authors.initials: GH
authors.lastname: Elta
authors.forename: Stuart
authors.initials: S
authors.lastname: Sherman
authors.forename: Akbar K
authors.initials: AK
authors.lastname: Waljee
authors.forename: Aparna
authors.initials: A
authors.lastname: Repaka
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Atkinson
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Cote
authors.forename: Richard S
authors.initials: RS
authors.lastname: Kwon
authors.forename: Lee
authors.initials: L
authors.lastname: McHenry
authors.forename: Cyrus R
authors.initials: CR
authors.lastname: Piraka
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Wamsteker
authors.forename: James L
authors.initials: JL
authors.lastname: Watkins
authors.forename: Sheryl J
authors.initials: SJ
authors.lastname: Korsnes
authors.forename: Suzette E
authors.initials: SE
authors.lastname: Schmidt
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Turner
authors.forename: Sylvia
authors.initials: S
authors.lastname: Nicholson
authors.forename: Evan L
authors.initials: EL
authors.lastname: Fogel
mesh_terms: D000285:Administration, Rectal; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization; D006801:Humans; D007213:Indomethacin / Q000009:adverse effects / Q000627:therapeutic use*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D012307:Risk Factors; D046628:Sphincter of Oddi Dysfunction / Q000150:complications
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007213:Indomethacin