title: Nafamostat mesilate for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a prospective, randomized, double-blind, controlled trial.
abstract: OBJECTIVE
  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.affiliation: Division of Gastroenterology and Hepatology, Hallym University College of Medicine, Anyang, Republic of Korea. stanyoo@hallym.ac.kr
authors.forename: Kyo-Sang
authors.initials: KS
authors.lastname: Yoo
authors.forename: Kyung Rim
authors.initials: KR
authors.lastname: Huh
authors.forename: Yu Jin
authors.initials: YJ
authors.lastname: Kim
authors.forename: Kyoung Oh
authors.initials: KO
authors.lastname: Kim
authors.forename: Cheol Hee
authors.initials: CH
authors.lastname: Park
authors.forename: Taeho
authors.initials: T
authors.lastname: Hahn
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Jong Hyeok
authors.initials: JH
authors.lastname: Kim
authors.forename: Choong Kee
authors.initials: CK
authors.lastname: Park
authors.forename: Young-Jun
authors.initials: YJ
authors.lastname: Kwon
authors.forename: Glen A
authors.initials: GA
authors.lastname: Lehman
mesh_terms: D000328:Adult; D000368:Aged; D001550:Benzamidines; D016009:Chi-Square Distribution; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006146:Guanidines / Q000008:administration & dosage*; D006801:Humans; D007196:Indiana; D007262:Infusions, Intravenous; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D011480:Protease Inhibitors / Q000008:administration & dosage*; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D001550:Benzamidines; D006146:Guanidines; D011480:Protease Inhibitors; C032855:nafamostat