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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00409084
First received: December 6, 2006
Last updated: July 2, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Esophageal Varices
 Procedure: endoscopic variceal band ligation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • first variceal bleed [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • liver function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • encephalopathy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • frequency of other complications of cirrhosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • cost utility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • patient preference [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: December 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
endoscopic variceal band ligation
 Procedure: endoscopic variceal band ligation
endoscopic variceal band ligation
Active Comparator: 2
subjects will receive nadolol (beta blocker) at 20mg/day with dose titration
 Procedure: endoscopic variceal band ligation
endoscopic variceal band ligation

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409084

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Arun J Sanyal, M.D. Division of Gastroenterology, Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Arun J. Sanyal, MD, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00409084     History of Changes
Other Study ID Numbers: HM10546
Study First Received: December 6, 2006
Last Updated: July 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
varices
band ligation
portal hypertension
 primary prophylaxis
cirrhosis
beta blockers

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal and Gastric Varices
Hemorrhage
Varicose Veins
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
 Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013