A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding (AVB-EVL+S)

Govind Ballabh Pant Hospital

Status: Completed

Conditions: Acute Bleeding Esophageal Varices; Portal Hypertension; Cirrhosis

Treatments: Drug: Placebo; Drug: Somatostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01267669

2005-PHT-01

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of portal hypertension
• Having hematemesis and/or melena within 24 hour prior to admission
• Source of bleeding should be esophageal varices

Exclusion criteria

• Non-cirrhotic cause of portal hypertension
• Age <12 or >75 years
• Hepatic encephalopathy grade 3 or 4
• Renal failure with serum creatinine >2 mg/dL
• Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
• Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding
• Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital
• Patients with history of surgery for portal hypertension or TIPS
• Concomitant severe cardio-pulmonary disease
• Concomitant malignancy
• HVPG not possible within 24 hrs of presentation
• Patients refusing to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

EVL plus Somatostatin

Experimental group

Description:

Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days

Treatment:

Drug: Somatostatin

EVL plus Placebo

Placebo Comparator group

Description:

Emergency EVL plus placebo infusion for 5 days

Treatment:

Drug: Placebo