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

Korea University

Status and phase: Unknown; Phase 4

Conditions: Cirrhosis; Variceal Bleeding

Treatments: Procedure: endoscopic band ligation; Procedure: EBL+Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00966121

EBLPPL-1

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Endoscopic band ligation

Active Comparator group

Description:

Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval

Treatment:

Procedure: endoscopic band ligation

EBL+Propranolol

Active Comparator group

Description:

Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min

Treatment:

Procedure: EBL+Propranolol