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

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Varices

Intervention / Treatment
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* Procedure: endoscopic variceal band ligation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>endoscopic variceal band ligation | Procedure: endoscopic variceal band ligation<br>* endoscopic variceal band ligation<br>|
| Active Comparator: 2<br>subjects will receive nadolol (beta blocker) at 20mg/day with dose titration | Procedure: endoscopic variceal band ligation<br>* endoscopic variceal band ligation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first variceal bleed |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 2 years | 
| liver function |  | 1 year | 
| encephalopathy |  | 1 year | 
| quality of life |  | 1 year | 
| frequency of other complications of cirrhosis |  | 2 years | 
| cost utility |  | 1 year | 
| patient preference |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varices, band ligation, portal hypertension, primary prophylaxis, cirrhosis, beta blockers