Prevention of Post-ERCP Pancreatitis with Somatostatin Versus Gabexate Mesilate: A Randomized Placebo Controlled Multicenter Study

Abstract

Background: Pancreatitis represents the most severe and unpredictable complication of ERCP and the efficacy of its prevention by pharmacological treatment is still uncertain. Aim of the Study: To assess the efficacy of either somatostatin or gabexate mesylate versus placebo in preventing ERCP-related pancreatitis. Material and Methods: In a prospective randomized multicenter study 661 consecutive patients (338 males, 312 females, mean age 66,2 years) undergoing ERCP were assigned to receive: A) placebo as a saline infusion of 500 ml in 12 hours (217 patients), B) somatostatin 3 mg in 12 hours (214 patients) or C) gabexate mesylate 1,2 g in 12 hours (219 patients) starting 60 minutes prior to the endoscopic procedure. 11 patients were excluded for various reasons. Patients with acute pancreatitis or choledochoco-duodenal anastomosis were also excluded from the study. Continuous abdominal pain for more than 24 hours associated with amylase increase of more than 5 times was considered as post-ERCP pancreatitis. Results: 21 patients (3.2%) presented clinical, laboratory and imaging features of acute pancreatitis, in 3 cases of severe form (0,46%). No significant difference was observed among the placebo (6 patients - 2,7%), somatostatin (8 patients - 3,8%) and gabexate (7 patients - 3,1%) groups. The 3 cases of severe pancreatitis were equally distributed. Incidence was higher in females (14/21, 66,6%), but without significant difference. Conclusions: Prophylactic pharmacological treatment with somatostatin or gabexate mesilate was unable to prevent post-ERCP pancreatitis. By now, only an appropriate indication and skillness of the endoscopy team seems to reduce the risk of this complication.