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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:
Sponsor: Virginia Commonwealth University

Current Primary Outcome: first variceal bleed [ Time Frame: 2 years ]

Original Primary Outcome: first variceal bleed

Current Secondary Outcome:

  • survival [ Time Frame: 2 years ]
  • liver function [ Time Frame: 1 year ]
  • encephalopathy [ Time Frame: 1 year ]
  • quality of life [ Time Frame: 1 year ]
  • frequency of other complications of cirrhosis [ Time Frame: 2 years ]
  • cost utility [ Time Frame: 1 year ]
  • patient preference [ Time Frame: 1 year ]


Original Secondary Outcome:

  • survival
  • liver function
  • encephalopathy
  • quality of life
  • frequency of other complications of cirrhosis
  • cost utility
  • patient preference


Information By: Virginia Commonwealth University

Dates:
Date Received: December 6, 2006
Date Started: December 2006
Date Completion:
Last Updated: July 2, 2010
Last Verified: July 2010