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

NCT00409084 | Terminated Phase 3 DMC

• 1 other identifier: HM10546
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

varices; band ligation; portal hypertension; primary prophylaxis; cirrhosis; beta blockers

Outcome Measures

Primary Outcomes (1)

• first variceal bleed

  2 years

Secondary Outcomes (7)

• survival

  2 years

• liver function

  1 year

• encephalopathy

  1 year

• quality of life

  1 year

• frequency of other complications of cirrhosis

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

endoscopic variceal band ligation

Procedure: endoscopic variceal band ligation

2

ACTIVE COMPARATOR

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

Procedure: endoscopic variceal band ligation

Interventions

endoscopic variceal band ligation PROCEDURE

endoscopic variceal band ligation

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cirrhosis
• medium to large varices

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices; Varicose Veins; Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arun J Sanyal, M.D.

  Division of Gastroenterology, Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 8, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 5, 2010

Record last verified: 2010-07

Locations

US (1)