Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment
Information source: Korea University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Variceal Bleeding
Intervention: endoscopic band ligation (Procedure); Endoscopic band ligation and propranolol (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korea University Overall contact:
Soon Ho Um, Prof, Phone: 82-2-920-5019, Email: umsh@korea.ac.kr
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. 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.
Clinical Details
Official title: RCT Comparing the Efficacies of Endoscopic Band Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding in Patients With Previous Endoscopic Variceal Treatment
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rebleeding from esophageal varices
Secondary outcome: Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
- 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
Locations and Contacts
Soon Ho Um, Prof, Phone: 82-2-920-5019, Email: umsh@korea.ac.kr
Korea University Anam Hospital, Seoul 136-705, Korea, Republic of; Recruiting
Additional Information
Starting date: August 2008
Ending date: July 2013
Last updated: August 25, 2009
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