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

Primary Purpose

Cirrhosis, Variceal Bleeding

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
endoscopic band ligation
EBL+Propranolol
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis focused on measuring Cirrhosis, Esophagus Disorders, Varicose Veins

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endoscopic band ligation

EBL+Propranolol

Arm Description

Perform endoscopic band ligation (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

Outcomes

Primary Outcome Measures

Rebleeding from esophageal varices
Rebleeding from esophageal varices

Secondary Outcome Measures

Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events

Full Information

First Posted
August 25, 2009
Last Updated
August 22, 2017
Sponsor
Korea University
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1. Study Identification

Unique Protocol Identification Number
NCT00966121
Brief Title
Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Variceal Bleeding
Keywords
Cirrhosis, Esophagus Disorders, Varicose Veins

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic band ligation
Arm Type
Active Comparator
Arm Description
Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
Arm Title
EBL+Propranolol
Arm Type
Active Comparator
Arm Description
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
Intervention Type
Procedure
Intervention Name(s)
endoscopic band ligation
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
EBL+Propranolol
Intervention Description
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 Measure Information:
Title
Rebleeding from esophageal varices
Description
Rebleeding from esophageal varices
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
Description
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soon Ho Um, Prof
Phone
82-2-920-5019
Email
umsh@korea.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yeon Seok Seo, MD
Phone
82-2-920-6608
Email
drseo@korea.ac.kr
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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