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Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

This study is currently recruiting participants.
Verified August 2017 by Soon Ho Um, Korea University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965900
First Posted: August 26, 2009
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Soon Ho Um, Korea University
  Purpose
This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.

Condition Intervention Phase
Variceal Bleeding Cirrhosis Procedure: Endoscopic band ligation Drug: Propranolol Procedure: EBL+Propranolol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by Soon Ho Um, Korea University:

Primary Outcome Measures:
  • First esophageal variceal bleeding [ Time Frame: 3 years after enrollment ]
    First esophageal variceal bleeding after enrollment


Secondary Outcome Measures:
  • Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events [ Time Frame: 3 years after enrollment ]
    Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events


Estimated Enrollment: 288
Study Start Date: September 2006
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endoscopic band ligation
Endoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
Procedure: Endoscopic band ligation
  • Perform EBL within 7 days after randomization
  • Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (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).
Other Name: EBL
Active Comparator: Propranolol
start with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Drug: Propranolol
  • start with 20 mg of propranolol b.i.d
  • Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 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)
Other Name: Beta blocker
Active Comparator: EBL+Propranolol
  • EBL until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
  • start with 20 mg of propranolol b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Procedure: EBL+Propranolol
  1. EBL

    • Perform EBL within 7 days after randomization
    • Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (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).
  2. Propranolol

    • start with 20 mg b.i.d
    • Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 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)
Other Name: EBL+Beta blocker

Detailed Description:
Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
  Eligibility

Information from the National Library of Medicine

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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
  • Esophageal varices with high bleeding risk: more than F2 and red color sign
  • No previous history of upper gastrointestinal bleeding
  • No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
  • Do not take beta-blocker, ACE inhibitor, or nitrate
  • Child-Pugh score <12

Exclusion Criteria:

  • Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
  • Portal vein thrombosis
  • Uncontrolled ascites or hepatic encephalopathy
  • Severe coagulation disorder: prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3
  • Medium or large sized gastric or duodenal varices
  • Coexisting malignancy
  • Severe cardiovascular disorder, renal failure, peritonitis, sepsis
  • Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer
  • Contraindication to beta-blocker
  • Pregnancy
  • Refusal to give consent to participate in the trial
  Contacts and Locations
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): NCT00965900


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
Investigators
Principal Investigator: Soon Ho Um, Prof Korea University
  More Information

Responsible Party: Soon Ho Um, Professor, Korea University
ClinicalTrials.gov Identifier: NCT00965900     History of Changes
Other Study ID Numbers: RCTPEBL
First Submitted: August 25, 2009
First Posted: August 26, 2009
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:
Hemorrhage
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Propranolol
Adrenergic beta-Antagonists
Proton Pump Inhibitors
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Enzyme Inhibitors