Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial

JOP. 2012 Sep 10;13(5):514-8. doi: 10.6092/1590-8577/855.

Abstract

Context: 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.

Design: Randomized, double-blind, placebo controlled trial at a single academic medical center.

Intervention: 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.

Patients: Thirty-four patients received aprepitant and 39 patients received placebo.

Statistics: 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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Antiemetics / administration & dosage
  • Antiemetics / therapeutic use
  • Aprepitant
  • Cholangiopancreatography, Endoscopic Retrograde / adverse effects*
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Morpholines / administration & dosage
  • Morpholines / therapeutic use*
  • Pancreatitis / etiology
  • Pancreatitis / prevention & control*
  • Pilot Projects
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Antiemetics
  • Morpholines
  • Aprepitant