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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.
Age
12 - 75 years
Sex
ALL
Healthy Volunteers
No
Department of Gastroenterology, G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India
Start Date
November 1, 2005
Primary Completion Date
November 1, 2009
Completion Date
November 1, 2009
Last Updated
December 28, 2010
61
ACTUAL participants
Somatostatin
DRUG
Placebo
DRUG
Lead Sponsor
Govind Ballabh Pant Hospital
NCT02417740
NCT05597488
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06932783