Pilot Study of Aprepitant for Prevention of Post-ERCP Pancreatitis in High Risk Patients: A Phase II Randomized, Double-Blind Placebo Controlled Trial

  • Tilak Upendra Shah Duke University Medical Center. Durham, VA, USA
  • Rodger Liddle Duke University Medical Center. Durham, VA, USA
  • M Stanley Branch Duke University Medical Center. Durham, VA, USA
  • Paul Jowell Duke University Medical Center. Durham, VA, USA
  • Jorge Obando Duke University Medical Center. Durham, VA, USA
  • Martin Poleski Duke University Medical Center. Durham, VA, USA
Keywords: aprepitant, Cholangiopancreatography, Endoscopic Retrograde, Pancreatitis, Receptors, Neurokinin-1

Abstract

Objectives Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis. 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.

Image: Duke University  School of Medicine. Durham, VA, USA.

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Author Biographies

Tilak Upendra Shah, Duke University Medical Center. Durham, VA, USA

Fellow, Divison of Gastroenterology

Rodger Liddle, Duke University Medical Center. Durham, VA, USA

Division of Gastroenterology, Professor

M Stanley Branch, Duke University Medical Center. Durham, VA, USA
Division of Gastroenterology, Professor
Paul Jowell, Duke University Medical Center. Durham, VA, USA
Division of Gastroenterology, Professor
Jorge Obando, Duke University Medical Center. Durham, VA, USA
Division of Gastroenterology, Associate Professor
Martin Poleski, Duke University Medical Center. Durham, VA, USA

Division of Gastroenterology, Professor

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Duke University School of Medicine. Durham, VA, USA
Published
2012-09-10
How to Cite
ShahT., LiddleR., BranchM., JowellP., ObandoJ., & PoleskiM. (2012). Pilot Study of Aprepitant for Prevention of Post-ERCP Pancreatitis in High Risk Patients: A Phase II Randomized, Double-Blind Placebo Controlled Trial. JOP. Journal of the Pancreas, 13(5), 514-518. https://doi.org/10.6092/1590-8577/855
Section
ORIGINAL ARTICLES