Three-day versus five-day somatostatin infusion combination with endoscopic variceal ligation in the prevention of early rebleeding following acute variceal hemorrhage: A randomized controlled trial

Abstract

© 2015 John Wiley & Sons, Ltd. Aim: Combined pharmacological and endoscopic therapy is recommended for initial treatment of acute variceal bleeding (AVB). The optimal duration of therapy with a vasoactive agent is not well established. The aim of this study was to compare the efficacy and safety of 3-day and 5-day somatostatin treatment in the prevention of early rebleeding after endoscopic variceal ligation (EVL). Methods: In a double-blind, prospective trial, cirrhotic patients with AVB who underwent EVL were randomly assigned to receive a continuous infusion of somatostatin for either 3days or 5days. Results: A total of 95 patients were enrolled; 50 patients in the 3-day group and 45 patients in the 5-day group after initial hemostasis by combination therapy with somatostatin and EVL. Both groups were comparable in terms of baseline data. Very early and early rebleeding within 5days and 42days occurred in one and three patient (2%, 6%) in the 3-day group and three and two patients (6.67%, 4.45%) in the 5-day group (P=0.342, 0.735), respectively. Overall, eight patients died (three from variceal rebleeding and five from causes other than variceal bleed); four (8%) in the 3-day group and four (8.89%) in the 5-day group (P=0.876). Multivariate analysis revealed that none of the factors was a predictor of rebleeding. No serious side-effects and complications were observed. Conclusion: A 3-day course of somatostatin is as effective as a 5-day course for the control of variceal bleeding and prevention of early rebleeding when used as combination therapy with EVL.