title: Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial.
abstract: BACKGROUND
  Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis.
  
  
  OBJECTIVE
  Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant) at preventing post-ERCP pancreatitis in high risk patients.
  
  
  METHODS
  Randomized, double-blind, placebo controlled trial at a single academic medical center.
  
  
  METHODS
  Patients at high risk for post-ERCP pancreatitis received either placebo or oral aprepitant administered 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose.
  
  
  METHODS
  Thirty-four patients received aprepitant and 39 patients received placebo.
  
  
  METHODS
  Fisher's exact test was used to compare incidence of post-ERCP pancreatitis in the two groups.
  
  
  RESULTS
  Baseline characteristics were similar between the two groups. Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group. Hospitalization within 7 days post-procedure for abdominal pain that did not meet criteria for acute pancreatitis occurred in 6 and 9 patients in the aprepitant and placebo groups respectively (P=0.772).
  
  
  CONCLUSIONS
  Aprepitant did not lower incidence of post-ERCP pancreatitis in this preliminary human study. Larger studies potentially using the recently available intravenous formulation are necessary to conclusively clarify the efficacy of aprepitant in this setting.
authors.affiliation: Duke University Medical Center, Durham, NC 27710, USA. tilak.shah@duke.edu
authors.forename: Tilak Upendra
authors.initials: TU
authors.lastname: Shah
authors.forename: Rodger
authors.initials: R
authors.lastname: Liddle
authors.forename: M Stanley
authors.initials: MS
authors.lastname: Branch
authors.forename: Paul
authors.initials: P
authors.lastname: Jowell
authors.forename: Jorge
authors.initials: J
authors.lastname: Obando
authors.forename: Martin
authors.initials: M
authors.lastname: Poleski
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use; D000077608:Aprepitant; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000627:therapeutic use*; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D010865:Pilot Projects; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000932:Antiemetics; D009025:Morpholines; D000077608:Aprepitant