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

Phase 4

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

• Registration Number: NCT00966082
• Lead Sponsor: Korea University

Brief Summary

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

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.

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: 2017-08-21
• Last Update Posted: 2017-08-22
• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic band ligation	endoscopic band ligation	Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval
endoscopic band ligation+Propranolol	endoscopic band ligation+Propranolol	Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval, with propranolol

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