title: Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients.
abstract: OBJECTIVE
  Rectal indomethacin, a nonsteroidal anti-inflammatory drug, is given to prevent pancreatitis in high-risk patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), based on findings from clinical trials. The European Society for Gastrointestinal Endoscopy guidelines recently recommended prophylactic rectal indomethacin for all patients undergoing ERCP, including those at average risk for pancreatitis. We performed a randomized controlled trail to investigate the efficacy of this approach.
  
  
  METHODS
  We performed a prospective, double-blind, placebo-controlled trial of 449 consecutive patients undergoing ERCP at Dartmouth Hitchcock Medical Center, from March 2013 through December 2014. Approximately 70% of the cohort were at average risk for PEP. Subjects were assigned randomly to groups given either a single 100-mg dose of rectal indomethacin (n = 223) or a placebo suppository (n = 226) during the procedure. The primary outcome was the development of post-ERCP pancreatitis (PEP), defined by new upper-abdominal pain, a lipase level more than 3-fold the upper limit of normal, and hospitalization after ERCP for 2 consecutive nights.
  
  
  RESULTS
  There were no differences between the groups in baseline clinical or procedural characteristics. Sixteen patients in the indomethacin group (7.2%) and 11 in the placebo group (4.9%) developed PEP (P = .33). Complications and the severity of PEP were similar between groups. Per a priori protocol guidelines, the study was stopped owing to futility.
  
  
  CONCLUSIONS
  In a randomized controlled study of consecutive patients undergoing ERCP, rectal indomethacin did not prevent post-ERCP pancreatitis. ClincialTrials.gov no: NCT01774604.
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; Section of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania. Electronic address: jlevenick@hmc.psu.edu.
authors.forename: John M
authors.initials: JM
authors.lastname: Levenick
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Gordon
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Fadden
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: L Campbell
authors.initials: LC
authors.lastname: Levy
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Rockacy
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Hyder
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Brian E
authors.initials: BE
authors.lastname: Lacy
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Steven P
authors.initials: SP
authors.lastname: Bensen
authors.affiliation: Investigational Pharmacy, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Douglas D
authors.initials: DD
authors.lastname: Parr
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Timothy B
authors.initials: TB
authors.lastname: Gardner
mesh_terms: D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000285:Administration, Rectal; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000032:analysis; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage* / Q000009:adverse effects; D008049:Lipase / Q000032:analysis; D008297:Male; D018447:Medical Futility; D008875:Middle Aged; D009513:New Hampshire; D010195:Pancreatitis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D015854:Up-Regulation
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D015415:Biomarkers; D008049:Lipase; C518354:PNLIP protein, human; D007213:Indomethacin
keywords: ESGE Recommendation; Inflammation; NSAID; Pancreas