title: Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.
abstract: OBJECTIVE
  A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach.
  
  
  METHODS
  We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both.
  
  
  RESULTS
  After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP.
  
  
  CONCLUSIONS
  This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan 48109, USA. badihe@umich.edu
authors.forename: B Joseph
authors.initials: BJ
authors.lastname: Elmunzer
authors.forename: Peter D R
authors.initials: PD
authors.lastname: Higgins
authors.forename: Sameer D
authors.initials: SD
authors.lastname: Saini
authors.forename: James M
authors.initials: JM
authors.lastname: Scheiman
authors.forename: Robert A
authors.initials: RA
authors.lastname: Parker
authors.forename: Amitabh
authors.initials: A
authors.lastname: Chak
authors.forename: Joseph
authors.initials: J
authors.lastname: Romagnuolo
authors.forename: Patrick
authors.initials: P
authors.lastname: Mosler
authors.forename: Rodney A
authors.initials: RA
authors.lastname: Hayward
authors.forename: Grace H
authors.initials: GH
authors.lastname: Elta
authors.forename: Sheryl J
authors.initials: SJ
authors.lastname: Korsnes
authors.forename: Suzette E
authors.initials: SE
authors.lastname: Schmidt
authors.forename: Stuart
authors.initials: S
authors.lastname: Sherman
authors.forename: Glen A
authors.initials: GA
authors.lastname: Lehman
authors.forename: Evan L
authors.initials: EL
authors.lastname: Fogel
mesh_terms: D000285:Administration, Rectal; D000328:Adult; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000191:economics; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents / Q000191:economics*; D016896:Treatment Outcome
chemical_list: D007213:Indomethacin