EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment

Study Overview
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Brief Summary
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This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Detailed Description
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Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Official Title
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RCT Comparing the Efficacies of Endoscopic Band Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding in Patients With Previous Endoscopic Variceal Treatment

Conditions
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Cirrhosis, Variceal Bleeding

Intervention / Treatment
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* Procedure: endoscopic band ligation
* Procedure: endoscopic band ligation+Propranolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis Age between 18 and 70 years Successful control of esophageal variceal bleeding within 6 weeks before enrollment Exclusion Criteria: Gastric variceal bleeding Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min Portal vein thrombosis Prominent hepatic encephalopathy Coexisting untreated malignancy Severe cerebrovascular or cardiovascular disease, renal failure No previous history of endoscopic, radiologic, or surgical treatment for varices or ascites Contraindication to beta-blocker Pregnancy Refusal to give consent to participate in the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic band ligation<br>Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval | Procedure: endoscopic band ligation<br>* Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval<br>|
| Active Comparator: endoscopic band ligation+Propranolol<br>Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval, with propranolol | Procedure: endoscopic band ligation+Propranolol<br>* Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding from esophageal varices | Rebleeding from esophageal varices | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events | Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Esophagus Disorders, Varicose Veins