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

August 22, 2017 updated by: Soon Ho Um, Korea University

RCT Comparing the Efficacies of Endoscopic Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 136-705
        • Recruiting
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding from esophageal varices
Time Frame: 2 years
Rebleeding from esophageal varices
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
Time Frame: 2 years
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ANTICIPATED)

July 1, 2019

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (ESTIMATE)

August 26, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBLPPL-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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