Randomized controlled trial of sclerotherapy versus somatostatin infusion in the prevention of early rebleeding following acute variceal hemorrhage in patients with cirrhosis

Background/Aims: Early rebleeding is a very frequent complication of variceal hemorrhage, Sclerotherapy effectively controls variceal hemorrhage and prevents early rebleeding. Somatostatin infusion is as effective as sclerotherapy in controlling variceal hemorrhage, but no study has evaluated the efficacy of 5-day somatostatin infusion in preventing early rebleeding after the initial control of bleeding. The aim of the study was to compare the efficacy and safety of somatostatin and sclerotherapy in the prevention of early variceal rebleeding in cirrhotic patients. Methods: The study included 169 patients with acute variceal hemorrhage who were randomized within 24 h of controlling the acute bleeding to receive either sclerotherapy (n=79) or continuous somatostatin infusion for 5 days (250 mu g/h after a 250-mu g bolus, repeated every 24 h, n=90), Success of therapy was defined by absence of rebleeding during the 5 days following randomization, Results: Early (5 days) rebleeding occurred in 12/79 patients treated with sclerotherapy vs 14/90 of those receiving somatostatin (NS), The treatment was equally effective in Child's C patients (sclerotherapy: 18/20; somatostatin: 17/20; NS) and Child's A+B patients (sclerotherapy: 49/59; somatostatin: 59/70; NS), Complications occurred in 19/79 patients receiving sclerotherapy vs 4/90 in the somatostatin group (p=0.00019), being severe in 6 vs 0 patients (p=0.0094). There were no differences between the two groups in the incidence of 6-week rebleeding (14% vs 15%, NS) and mortality (9% vs 9%). Conclusions: Continuous somatostatin infusion is as effective as sclerotherapy in preventing early variceal rebleeding and maintaining low mortality following acute variceal hemorrhage. Somatostatin is associated with a lower rate of complications than sclerotherapy.