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

Phase 4

• Conditions: Cirrhosis; Variceal Bleeding
• Interventions: Procedure: EBL+Propranolol; Procedure: endoscopic band ligation

• Registration Number: NCT00966121
• Lead Sponsor: Korea University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23
• Primary Completion: 2019-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBL+Propranolol	EBL+Propranolol	Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
Endoscopic band ligation	endoscopic band ligation	Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval

Primary Outcome Measures

Name	Time	Method
Rebleeding from esophageal varices	2 years	Rebleeding from esophageal varices

Secondary Outcome Measures

Name	Time	Method
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events	2 years	Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of