EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment
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
1 other identifier
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedAugust 22, 2017
August 1, 2017
10.9 years
August 25, 2009
August 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rebleeding from esophageal varices
Rebleeding from esophageal varices
2 years
Secondary Outcomes (1)
Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events
2 years
Study Arms (2)
Endoscopic band ligation
ACTIVE COMPARATORPerform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval
endoscopic band ligation+Propranolol
ACTIVE COMPARATORPerform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval, with propranolol
Interventions
Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
Eligibility Criteria
You may qualify if:
- Liver cirrhosis
- Age between 18 and 70 years
- Successful control of esophageal variceal bleeding within 6 weeks before enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Universitylead
Study Sites (1)
Korea University Anam Hospital
Seoul, 136-705, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soon Ho Um, Prof
Korea University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2009
First Posted
August 26, 2009
Study Start
August 1, 2008
Primary Completion
July 1, 2019
Study Completion
July 1, 2021
Last Updated
August 22, 2017
Record last verified: 2017-08