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Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding

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ClinicalTrials.gov Identifier: NCT00966121
Recruitment Status : Recruiting
First Posted : August 26, 2009
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Soon Ho Um, Korea University

Brief 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. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.

Condition or disease Intervention/treatment Phase
Cirrhosis Variceal Bleeding Procedure: endoscopic band ligation Procedure: EBL+Propranolol Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RCT Comparing the Efficacies of Endoscopic Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding
Study Start Date : August 2008
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Rebleeding from esophageal varices [ Time Frame: 2 years ]
    Rebleeding from esophageal varices


Secondary Outcome Measures :
  1. Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events [ Time Frame: 2 years ]
    Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966121


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

Responsible Party: Soon Ho Um, Professor, Korea University
ClinicalTrials.gov Identifier: NCT00966121     History of Changes
Other Study ID Numbers: EBLPPL-1
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by Soon Ho Um, Korea University:
Cirrhosis
Esophagus Disorders
Varicose Veins

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents