NCT01267669

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

A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Govind Ballabh Pant Hospital · Other Government
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Bleeding Esophageal Varices
• Portal Hypertension
• Cirrhosis

Interventions

Type	Name	Description
DRUG	Somatostatin	Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
DRUG	Placebo	Emergency EVL plus placebo infusion for 5 days

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2010-12-28
• Last updated: 2010-12-28

Locations

1 site across 1 country: India