Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding

Study Overview
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Brief Summary
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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. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.

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

Conditions
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Cirrhosis, Variceal Bleeding

Intervention / Treatment
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* Procedure: endoscopic band ligation
* Procedure: EBL+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 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 esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval | Procedure: endoscopic band ligation<br>* Perform EBL within 7 days after randomization Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (at 4,8,12 weeks after initial treatment). Acid suppression using proton pump inhibitor until eradicated. After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).<br>|
| Active Comparator: EBL+Propranolol<br>Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min | Procedure: EBL+Propranolol<br>* Start with 20 mg b.i.d Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)<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