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

This study is currently recruiting participants.
Verified by Virginia Commonwealth University, December 2006

Sponsored by: Virginia Commonwealth University
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00409084
  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 III

MedlinePlus related topics:   Cirrhosis    Endoscopy    Esophagus Disorders    High Blood Pressure    Varicose Veins   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding

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 ]

Estimated Enrollment:   80
Study Start Date:   December 2006
Estimated Study Completion Date:   December 2008

Arms Assigned Interventions
1: Active Comparator
endoscopic variceal band ligation
Procedure: endoscopic variceal band ligation
endoscopic variceal band ligation
2: Active Comparator
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

Contacts
Contact: Arun J Sanyal, M.D.     804 828 6314     ajsanyal@hsc.vcu.edu    
Contact: Amrita Sethi, M.D.     804 828 6314     asethi@vcu.edu    

Locations
United States, Virginia
Virginia Commonwealth University     Recruiting
      Richmond, Virginia, United States, 23298
      Contact: Arun J Sanyal, M.D.     804-828-6314     ajsanyal@hsc.vcu.edu    
      Contact: Amrita Sethi, M.D.     804 828 6314     asethi@vcu.edu    
      Principal Investigator: Arun J Sanyal, M.D.            

Sponsors and Collaborators
Virginia Commonwealth University

Investigators
Principal Investigator:     Arun J Sanyal, M.D.     Division of Gastroenterology, Virginia Commonwealth University    
  More Information


Responsible Party:   Virginia Commonwealth University ( Arun J. Sanyal, MD )
Study ID Numbers:   HM10546
First Received:   December 6, 2006
Last Updated:   December 14, 2007
ClinicalTrials.gov Identifier:   NCT00409084
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Liver Diseases
Esophageal disorder
Gastrointestinal Diseases
Vascular Diseases
Liver Cirrhosis
Hypertension, Portal
Hemorrhage
Portal hypertension
Esophageal varices
Digestive System Diseases
Varicose Veins
Esophageal and Gastric Varices
Esophageal Diseases
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2008




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