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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:
ClinicalTrials.gov Identifier:
NCT00409084
First Posted: December 8, 2006
Last Update Posted: July 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Virginia Commonwealth University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Virginia Commonwealth University:

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

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Arun J. Sanyal, MD, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00409084     History of Changes
Other Study ID Numbers: HM10546
First Submitted: December 6, 2006
First Posted: December 8, 2006
Last Update Posted: July 5, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs