A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding

Summary

Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL. Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding. Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.

Timeline

Start

2005-11

Primary completion

2009-11

Completion

2009-11

Outcome

Missed primary endpoint

paper Within the initial 5-day period, the frequency of treatment failure was similar in both the groups (EVL plus somatostatin group 8/31 [26%] versus EVL plus placebo group 7/30 [23%]; P = 1.000). PMID 26628838 ↗

Publications

• Kumar A, Jha SK, Mittal VV, Sharma P, Sharma BC, Sarin SK. Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial. J Clin Exp Hepatol. 2015 Sep;5(3):204-12. doi: 10.1016/j.jceh.2015.06.001. Epub 2015 Jun 16.

Drugs

Indications