Trial record 5 of 542 for:
Open Studies | endoscopy
Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment
This study is currently recruiting participants.
Verified August 2009 by Korea University
Sponsor:
Korea University
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00966082
First received: August 25, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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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 4 |
| 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
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 May 16, 2013