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Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized,
Tilak Upendra Shah1, Rodger Liddle, M Stanley Branch
1Duke University Medical Center, Durham, NC 27710, USA. tilak.shah@duke.edu
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.
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