Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding

Phase 3

Terminated

• Conditions: Esophageal Varices
• Interventions: Procedure: endoscopic variceal band ligation

• Registration Number: NCT00409084
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). Using both therapies at the same time has not been studied. In this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). The efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-06
• Study First Posted: 2006-12-08
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-02
• Last Update Posted: 2010-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• cirrhosis
• medium to large varices

Exclusion Criteria

• contraindications to beta blockers
• refusal to give consent
• prior history of variceal hemorrhage
• creatinine > 1.5 mg/dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	endoscopic variceal band ligation	endoscopic variceal band ligation
2	endoscopic variceal band ligation	subjects will receive nadolol (beta blocker) at 20mg/day with dose titration

Primary Outcome Measures

Name	Time	Method
first variceal bleed	2 years

Secondary Outcome Measures

Name	Time	Method
survival	2 years
liver function	1 year
encephalopathy	1 year
quality of life	1 year
frequency of other complications of cirrhosis	2 years
cost utility	1 year
patient preference	1 year

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States