Cirrhosis Clinical Trial
Official title:
A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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