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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 February 07, 2013
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

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
Last updated: August 25, 2009

Page last updated: February 07, 2013

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