Abstract

Background: Very early rebleeding is frequently encountered in patients with acute esophageal variceal bleeding. We designed a trial to assess the efficacy and safety in patients with no active bleeding at endoscopy receiving banding ligation association with terlipressin to prevent very early rebleeding.

Methods: Patients with no active variceal bleeding at endoscopy were evaluated. Eligible patients were randomized to receive terlipressin infusion alone for 5 days (Terlipressin group) or banding ligation plus terlipressin infusion for 2 days (Combined group). Primary end points were treatment failure and very early rebleeding.

Results: Terlipressin group was composed of 46 patients, and Combined group was composed of 47 patients. Both groups were comparable in baseline data. 48-hour hemostasis was achieved in 91% in Terlipressin group and 98% in Combined group (p=0.20). Very early rebleeding within 48-120 hours occurred in 7 patients (15%) in the Terlipressin group but no patient (0%) in the Combined group (p=0.006). Treatment failure was 24% in Terlipressin group and 2% in Combined group (p=0.002). Multivariate analysis revealed that treatment (odds ratio 0.081; 95% confidence interval 0.010-0.627) was the only predictive factor of very early rebleeding. Blood requirement was significantly lower in the Combined group than in the Terlipressin group. Complications and six weeks survival were similar between both groups.

Conclusions: Combination of banding ligation and terlipressin infusion for 2 days was superior to single infusion of terlipressin 5 days in the reduction of very early rebleeding and treatment failure in patients with inactive variceal bleeding at endoscopy.