Nafamostat mesilate for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a prospective, randomized, double-blind, controlled trial.

Abstract

OBJECTIVES:

Pancreatitis is the most common major complication of endoscopic retrograde cholangiopancreatography (ERCP). Efforts have been made to identify pharmacologic agents capable of reducing its incidence and severity. The aim of this trial was to determine whether prophylactic nafamostat mesilate, a synthetic protease inhibitor, would reduce the frequency and severity of post-ERCP pancreatitis.

METHODS:

A total of 286 patients were randomized to receive either intravenous nafamostat mesilate or placebo 60 minutes before ERCP and for 6 hours after ERCP. A database was prospectively collected by a defined protocol. Standardized criteria were used to diagnose and grade the severity of pancreatitis.

RESULTS:

The groups were similar with regard to patient demographics and to patient and procedure risk factors for pancreatitis. The overall incidence of pancreatitis was 5.9%. It occurred in 4 (2.8%) of 143 patients in the nafamostat group and in 13 (9.1%) of 143 patients in the control group (P = 0.03). Pancreatitis was graded mild in 2.1% and moderate in 0.7% of the nafamostat group and mild in 7.0% and moderate in 2.1% of the control group. There was no significant difference between the groups in the severity of pancreatitis.

CONCLUSIONS:

Prophylactic intravenous nafamostat mesilate reduces the frequency of post-ERCP pancreatitis.

• Authors: Kyo-Sang Yoo, Kyung Rim Huh, Yu Jin Kim, Kyoung Oh Kim, Cheol Hee Park, Taeho Hahn, Sang Hoon Park, Jong Hyeok Kim, Choong Kee Park, Young-Jun Kwon, Glen A Lehman
• Journal: Pancreas (Pancreas) Vol. 40 Issue 2 Pg. 181-6 (Mar 2011) ISSN: 1536-4828 [Electronic] United States
• PMID: 21206331 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Benzamidines
• Guanidines
• Protease Inhibitors
• nafamostat

Topics

• Adult
• Aged
• Benzamidines
• Chi-Square Distribution
• Cholangiopancreatography, Endoscopic Retrograde (adverse effects)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Guanidines (administration & dosage)
• Humans
• Indiana
• Infusions, Intravenous
• Logistic Models
• Male
• Middle Aged
• Odds Ratio
• Pancreatitis (etiology, prevention & control)
• Prospective Studies
• Protease Inhibitors (administration & dosage)
• Risk Assessment
• Risk Factors
• Treatment Outcome