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

Published online

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Shah, TU; Liddle, R; Branch, MS; Jowell, P; Obando, J; Poleski, M

Published Date

  • September 10, 2012

Published In

Volume / Issue

  • 13 / 5

Start / End Page

  • 514 - 518

PubMed ID

  • 22964958

Pubmed Central ID

  • 22964958

Electronic International Standard Serial Number (EISSN)

  • 1590-8577

Digital Object Identifier (DOI)

  • 10.6092/1590-8577/855

Language

  • eng

Conference Location

  • Italy