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

Primary Purpose

Esophageal Varices

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
endoscopic variceal band ligation
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Varices focused on measuring varices, band ligation, portal hypertension, primary prophylaxis, cirrhosis, beta blockers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

endoscopic variceal band ligation

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

Outcomes

Primary Outcome Measures

first variceal bleed

Secondary Outcome Measures

survival
liver function
encephalopathy
quality of life
frequency of other complications of cirrhosis
cost utility
patient preference

Full Information

First Posted
December 6, 2006
Last Updated
July 2, 2010
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT00409084
Brief Title
Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
Official Title
Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices
Keywords
varices, band ligation, portal hypertension, primary prophylaxis, cirrhosis, beta blockers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
endoscopic variceal band ligation
Arm Title
2
Arm Type
Active Comparator
Arm Description
subjects will receive nadolol (beta blocker) at 20mg/day with dose titration
Intervention Type
Procedure
Intervention Name(s)
endoscopic variceal band ligation
Intervention Description
endoscopic variceal band ligation
Primary Outcome Measure Information:
Title
first variceal bleed
Time Frame
2 years
Secondary Outcome Measure Information:
Title
survival
Time Frame
2 years
Title
liver function
Time Frame
1 year
Title
encephalopathy
Time Frame
1 year
Title
quality of life
Time Frame
1 year
Title
frequency of other complications of cirrhosis
Time Frame
2 years
Title
cost utility
Time Frame
1 year
Title
patient preference
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun J Sanyal, M.D.
Organizational Affiliation
Division of Gastroenterology, Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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

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