Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding

November 19, 2020 updated by: E-DA Hospital

Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices

Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy & safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.

Study Type

Interventional

Enrollment (Actual)

65

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

  • Taiwan
      • Kaogsiung, Taiwan, 82445
        • E-DA 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

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cirrhosis with esophageal varices are larger than F2.
  2. No history of variceal bleeding.
  3. In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.

Exclusion Criteria:

  1. Association with HCC or other cancers .
  2. Refractory ascites.
  3. Jaundice, bilirubin > 5mg/dl.
  4. Encephalopathy.
  5. Cr.>3mg/dL.
  6. A-V,block bradycardia (PR < 60/mim).
  7. Hypotension systolic blood pressure<95/mmHg .
  8. Refusal to participate.
  9. Carvedilol allergy
  10. Second degree-third degree Atrio-ventricular block.
  11. Bradycardia.
  12. WPWsyndrome
  13. Hypotension
  14. Psychogenic shock.
  15. Asthma. All the patients are randomized based on a random number.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVL + carvedilol
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
Procedure: EVL + carvedilol
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
Active Comparator: carvedilol
carvedilol 6.25-12.5 mg per day
Drug: carvedilol
carvedilol 6.25mg-12.5 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients with first bleeding
Time Frame: 3 years
the difference of bleeding episode in both groups.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients with complications and mortality rates
Time Frame: 3 years
the difference of complications & survival curve between both groups.
3 years

Collaborators and Investigators

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

Sponsor

E-DA Hospital

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 (Actual)

July 8, 2011

Primary Completion (Actual)

July 30, 2015

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARVEDILOL

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.

Clinical Trials on Variceal Bleeding

Clinical Trials on EVL + carvedilol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe