Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment - Full Text View

Sponsor:	Korea University
Information provided by:	Korea University
ClinicalTrials.gov Identifier:	NCT00966082

Purpose

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.

Condition	Intervention	Phase
Cirrhosis Variceal Bleeding	Procedure: endoscopic band ligation Procedure: Endoscopic band ligation and propranolol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Endoscopy Esophagus Disorders Varicose Veins

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:

Rebleeding from esophageal varices [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Endoscopic band ligation Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval	Procedure: endoscopic band ligation Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
Active Comparator: EBL+Propranolol EBL	Procedure: Endoscopic band ligation and propranolol Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval Active Comparator: EBL+Propranolol Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966082

Contacts

Contact: Soon Ho Um, Prof	82-2-920-5019	umsh@korea.ac.kr
Contact: Yeon Seok Seo, MD	82-2-920-6608	drseo@korea.ac.kr

Locations

Korea, Republic of
Korea University Anam Hospital	Recruiting
Seoul, Korea, Republic of, 136-705

Sponsors and Collaborators

Korea University

More Information

No publications provided

Responsible Party:	Liver Cirrhosis Clinical Research Center, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Anam Hospital
ClinicalTrials.gov Identifier:	NCT00966082 History of Changes
Other Study ID Numbers:	EBLPPL-2
Study First Received:	August 25, 2009
Last Updated:	August 25, 2009
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Korea University:

Cirrhosis
Esophagus Disorders
Varicose Veins

Additional relevant MeSH terms:

Hemorrhage
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012