Use Of Nafamostat Mesilate And Gabexate Mesylate In The Prevention Of Post-Ercp Pancreatitis And Risk Factor Analysis: A Prospective, Randomized Trial

Background and Aims: Pancreatitis is the most common major complication of ERCP. The aim of this prospective controlled study was to determine whether prophylactic nafamostat mesilate and Gabexate mesylate may decrease the incidence of post-ERCP pancreatitis and to determine risk factors of post-ERCP pancreatitis. Method : From January, 2005 to Descember, 2006, a total of 950 patients (476 women and 474 men,with an average age of 65.17 ± 15.34 yr) who were scheduled to undergo ERCP underwent randomization. All patients undergoing ERCP were treated with Nafamostat mesilate or Gabexate mesylate or 5% dextrose solution. Datas were collected prior to the procedure, 4 hour after procedure and 24 hour after procedure. Main Outcome Measurements were the incidence of pancreatitis and hyperamylasemia, as well as factors associated with the development of pancreatitis. Results: The overall incidence of acute pancreatitis was 3.36% (32 of 950 patients). ERCP-induced pancreatitis occurred in 8 of 317 (2.5 %) patients treated with Nafamostat mesilate, in 6 of 316 (1.9%) patients treated with Gabexate mesylate and in 18 of 317 (5.6%) treated with placebo (p < 0.05). The results of incidence of post-ERCP pancreatic showed significant difference between Nafamostat mesilate between and placebo group, and significant difference between Gabexate mesylate between and placebo group. But, no significant defference was seen between Nafamostat mesilate between and Gabexate mesylate group. The results of analysis of risk factors for pancreatitis did not evidence any significant difference among groups. By univariate analysis, the significant risk factors were previous history of acute pancreatitis (OR:20.4), female sex (OR:3.0) and no CBD dilatation (OR:1.46). By multivariate, analysis, previous history of acute pancreatitis (OR:16.6) and female sex (OR:3.8) were significant risk factors. Conclusion : There was no clinical difference between the effect of preventive administration of Nafamostat Mesilate and that of gabexate mesylate on the incidence of post-ERCP pancreatitis. Nafamostat Mesilate may be equivalent in efficacy to gabexate for reducing the incidence of post-ERCP pancreatitis. Table 1Baseline Characteristics of Patients by Treatment Group nafamostat gabexate control Sex (M/F) 157/160 158/158 157/158 mean age(SD) 65.16(12.1) 65.2(12.6) 65.18(12.3) post-ERCP hyperamylasemia ∗ p < 0.01 16(5.0%) 15(4.7%) 28(8.8%) post-ERCP pancreatitis ∗ p < 0.01 8(2.5%) 6(1.9%) 18(5.67%) ∗ p < 0.01 Open table in a new tab