title: The risk of post-ERCP pancreatitis and the protective effect of rectal indomethacin in cases of attempted but unsuccessful prophylactic pancreatic stent placement.
abstract: BACKGROUND
  It is believed, based on limited observational data, that an unsuccessful attempt to place a prophylactic pancreatic stent substantially increases the risk of post-ERCP pancreatitis (PEP).
  
  
  OBJECTIVE
  To better understand the risk of PEP in patients with failed pancreatic stent placement (FPS) and the impact of rectal indomethacin on this risk.
  
  
  METHODS
  Secondary analysis of randomized, controlled trial data.
  
  
  METHODS
  University of Michigan and Indiana University.
  
  
  METHODS
  A total of 577 clinical trial participants at elevated risk for PEP.
  
  
  METHODS
  Pancreatic stent placement.
  
  
  METHODS
  Within the placebo group, we compared PEP rates in patients with FPS, patients who underwent successful stent placement, and in those without a stent attempt. We also performed a regression analysis evaluating the association between FPS and PEP. To define the protective effect of indomethacin, we repeated these analyses in the indomethacin group and in the full study cohort.
  
  
  RESULTS
  The incidence of PEP among patients in the placebo group who experienced FPS was 34.7%, significantly exceeding rates in patients who underwent successful stent placement (16.4%) and in those without a stent attempt (12.1%). After we adjusted for known PEP risk factors, FPS was found to be independently associated with PEP. Among the indomethacin group and in the full cohort, FPS was not associated with a higher risk of PEP.
  
  
  CONCLUSIONS
  Low event rate, FPS not prospectively captured.
  
  
  CONCLUSIONS
  FPS appears to confer an increased risk of PEP, which is attenuated by rectal indomethacin administration. These findings highlight the importance of adequate training and proficiency before endoscopists attempt pancreatic stent placement and the routine use of rectal indomethacin in high-risk ERCP cases.
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
authors.forename: Neel S
authors.initials: NS
authors.lastname: Choksi
authors.affiliation: Division of Gastroenterology, Indiana University Medical Center, Indianapolis, Indiana, USA.
authors.forename: Evan L
authors.initials: EL
authors.lastname: Fogel
authors.affiliation: Division of Gastroenterology, Indiana University Medical Center, Indianapolis, Indiana, USA.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Cote
authors.affiliation: Division of Gastroenterology, Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Romagnuolo
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
authors.forename: Grace H
authors.initials: GH
authors.lastname: Elta
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
authors.forename: James M
authors.initials: JM
authors.lastname: Scheiman
authors.affiliation: Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, Ohio, USA.
authors.forename: Amitabh
authors.initials: A
authors.lastname: Chak
authors.affiliation: Division of Digestive Diseases and Nutrition, University of Kentucky Medical Center, Lexington, Kentucky, USA; Division of Gastroenterology and Hepatology, Kantonsspital Graubuenden, Chur, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Mosler
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
authors.forename: Peter D R
authors.initials: PD
authors.lastname: Higgins
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
authors.forename: Sheryl J
authors.initials: SJ
authors.lastname: Korsnes
authors.affiliation: Division of Gastroenterology, Indiana University Medical Center, Indianapolis, Indiana, USA.
authors.forename: Suzette E
authors.initials: SE
authors.lastname: Schmidt
authors.affiliation: Division of Gastroenterology, Indiana University Medical Center, Indianapolis, Indiana, USA.
authors.forename: Stuart
authors.initials: S
authors.lastname: Sherman
authors.affiliation: Division of Gastroenterology, Indiana University Medical Center, Indianapolis, Indiana, USA.
authors.forename: Glen A
authors.initials: GA
authors.lastname: Lehman
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
authors.forename: B Joseph
authors.initials: BJ
authors.lastname: Elmunzer
mesh_terms: D000285:Administration, Rectal; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D015607:Stents
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007213:Indomethacin