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

NCT ID: NCT00409084

Last Updated: 2010-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-06-30

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.

Conditions

Esophageal Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

endoscopic variceal band ligation

Group Type: ACTIVE_COMPARATOR

endoscopic variceal band ligation

Intervention Type: PROCEDURE

endoscopic variceal band ligation

2

subjects will receive nadolol (beta blocker) at 20mg/day with dose titration

Group Type: ACTIVE_COMPARATOR

endoscopic variceal band ligation

Intervention Type: PROCEDURE

endoscopic variceal band ligation

Interventions

endoscopic variceal band ligation

endoscopic variceal band ligation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Virginia Commonwealth University

Principal Investigators

Arun J Sanyal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology, Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM10546

Identifier Type: -

Identifier Source: org_study_id