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

Not Applicable

Completed

• Conditions: Acute Bleeding Esophageal Varices; Portal Hypertension; Cirrhosis
• Interventions: Drug: Somatostatin; Drug: Placebo

• Registration Number: NCT01267669
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-12
• Study First Submitted: 2010-12-27
• Study First Submitted QC: 2010-12-27
• Last Update Submitted: 2010-12-27
• Study First Posted: 2010-12-28
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVL plus Somatostatin	Somatostatin	Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
EVL plus Placebo	Placebo	Emergency EVL plus placebo infusion for 5 days

Primary Outcome Measures

Name	Time	Method
Treatment failure	5 days	The primary endpoint was treatment failure, defined as the occurrence of any of the following within a period of 120 h (5 days) from the time of admission: (i) Fresh hematemesis ≥2 hr after EVL; or (ii) Death within 5 days.

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	During the same admission	Death during the same admission to the hospital
Transfusion requirement	During hospital stay	Amount of packed cell or FFP infusions received during the hospital stay
ICU stay in days	During the hospital stay	Number of dys the patient spent in ICU
Drug-related adverse effects	5 days	Adverse effects due to somatostatin or placebo infusion

Trial Locations

Locations (1)

Department of Gastroenterology, G B Pant Hospital; 🇮🇳 New Delhi, Delhi, India