RCT Comparing the Efficacies of Endoscopic Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Korea University
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Rebleeding from esophageal varices
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Endoscopic band ligation
Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
Intervention: endoscopic band ligation (Procedure)
EBL+Propranolol
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
Intervention: EBL+Propranolol (Procedure)
Outcomes
Primary Outcomes
Rebleeding from esophageal varices
Time Frame: 2 years
Rebleeding from esophageal varices
Secondary Outcomes
- Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events(2 years)
Investigators
Soon Ho Um
Professor
Korea University