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

Korea University1 site in 1 country180 target enrollmentAugust 2008

ConditionsCirrhosis Variceal Bleeding

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cirrhosis
Sponsor: Korea University
Enrollment: 180
Locations: 1
Primary Endpoint: Rebleeding from esophageal varices
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

July 2021

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Korea University

Responsible Party

Principal Investigator

Soon Ho Um

Professor

Korea University

Eligibility Criteria

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