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

Esophageal Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00409084
• Other study ID #: HM10546
• Status: Terminated
• Phase: Phase 3
• First received: December 6, 2006
• Last updated: July 2, 2010
• Start date: December 2006
• Est. completion date: June 2009

Study information

• Verified date: July 2010
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophageal Varices

Intervention

Procedure:
• endoscopic variceal band ligation
endoscopic variceal band ligation

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first variceal bleed		2 years	No
Secondary	survival		2 years	No
Secondary	liver function		1 year	No
Secondary	encephalopathy		1 year	No
Secondary	quality of life		1 year	No
Secondary	frequency of other complications of cirrhosis		2 years	No
Secondary	cost utility		1 year	No
Secondary	patient preference		1 year	No