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.
RCT Entities:
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: Brian F Niemeyer; Caitlin M Miller; Carmen Ledesma-Feliciano; James H Morrison; Rocio Jimenez-Valdes; Clarissa Clifton; Eric M Poeschla; Kambez H Benam Journal: Nano Sel Date: 2021-06-30
Authors: Joo Seong Kim; Sang Hyub Lee; Namyoung Park; Gunn Huh; Jung Won Chun; Jin Ho Choi; In Rae Cho; Woo Hyun Paik; Ji Kon Ryu; Yong-Tae Kim Journal: BMC Gastroenterol Date: 2022-05-31 Impact factor: 2.847
Authors: Behzad Hatami; Seyed Mohammad Hossein Kashfi; Mohammad Abbasinazari; Ehsan Nazemalhosseini Mojarad; Mohammad Amin Pourhoseingholi; Mohammad Reza Zali; Amir Houshang Mohammad Alizadeh Journal: Case Rep Gastroenterol Date: 2018-04-13