Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding

Study Overview
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Brief Summary
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Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy & safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.

Detailed Description
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Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.

Official Title
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Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices

Conditions
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Variceal Bleeding

Intervention / Treatment
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* Procedure: EVL + carvedilol
* Drug: carvedilol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhosis with esophageal varices are larger than F2. No history of variceal bleeding. In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs. Exclusion Criteria: Association with HCC or other cancers . Refractory ascites. Jaundice, bilirubin > 5mg/dl. Encephalopathy. Cr.>3mg/dL. A-V,block bradycardia (PR < 60/mim). Hypotension systolic blood pressure<95/mmHg . Refusal to participate. Carvedilol allergy Second degree-third degree Atrio-ventricular block. Bradycardia. WPWsyndrome Hypotension Psychogenic shock. Asthma. All the patients are randomized based on a random number.

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Experimental: EVL + carvedilol<br>EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day | Procedure: EVL + carvedilol<br>* EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day<br>|
| Active Comparator: carvedilol<br>carvedilol 6.25-12.5 mg per day | Drug: carvedilol<br>* carvedilol 6.25mg-12.5 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients with first bleeding | the difference of bleeding episode in both groups. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients with complications and mortality rates | the difference of complications & survival curve between both groups. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carvedilol, Banding ligation with Carvedilol, the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding