Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding
NCT ID: NCT00966121
Last Updated: 2017-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2008-08-31
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Endoscopic band ligation
Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
endoscopic band ligation
* Perform EBL within 7 days after randomization
* Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (at 4,8,12 weeks after initial treatment).
* Acid suppression using proton pump inhibitor until eradicated.
* After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
EBL+Propranolol
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
EBL+Propranolol
* Start with 20 mg b.i.d
* Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min
* After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Interventions
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endoscopic band ligation
* Perform EBL within 7 days after randomization
* Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (at 4,8,12 weeks after initial treatment).
* Acid suppression using proton pump inhibitor until eradicated.
* After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
EBL+Propranolol
* Start with 20 mg b.i.d
* Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min
* After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Eligibility Criteria
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Inclusion Criteria
* age between 18 and 70 years
* Successful control of esophageal variceal bleeding within 6 weeks before enrollment
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Korea University
OTHER
Responsible Party
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Soon Ho Um
Professor
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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EBLPPL-1
Identifier Type: -
Identifier Source: org_study_id
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