Preventing Recurrent Bleeding After Eradication of Esophageal Varices

April 12, 2016 updated by: Wen-Chi Chen, Kaohsiung Veterans General Hospital.

Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices

Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.

Study Type

Interventional

Enrollment (Anticipated)

212

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 Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Wen-Chi Chen, MD

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 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 20 to 80 years
  • Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
  • Stable hemodynamic condition for at least 3 days after banding ligation

Exclusion Criteria:

  • Hepatocellular carcinoma or other malignancy
  • Stroke or active sepsis
  • Chronic kidney disease under renal replacement therapy
  • Contraindications to non-selective beta-blockers
  • A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
  • Serum total bilirubin >10 mg/dL
  • Grade III/IV hepatic encephalopathy
  • Refractory ascites
  • Hepato-renal syndrome
  • Pregnancy
  • Severe heart failure (NYHA Fc III/IV)
  • Bronchial asthma or chronic obstructive pulmonary disease
  • Second or third degree atrioventricular block
  • Sick sinus syndrome
  • Pacemaker use
  • Severe hypotension
  • Refusal to participate

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Banding ligation group
Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.
Experimental: Propranolol group
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
Drug: propranolol
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent esophageal variceal bleeding
Time Frame: 6 years
recurrent esophageal variceal bleeding after eradication of esophageal varices
6 years
mortality or liver transplantation
Time Frame: 6 years
mortality or liver transplantation after eradication of esophageal varices
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effects
Time Frame: 6 years
adverse effects associated with non-selective beta-blockers and banding ligation
6 years

Collaborators and Investigators

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

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Wen-Chi Chen, MD, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2013

Primary Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS13-CT6-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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