Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.

November 14, 2017 updated by: Institute of Liver and Biliary Sciences, India

A Prospective Randomized Controlled Trial Comparing Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis

Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed to assess the rate of reduction of index bleed rate as well as survival difference between the groups.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver and Biliary Sciences

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of cirrhosis with Hepatocellular carcinoma and portal vein thrombosis
  • Presence of large oesophageal varices or small with high risk

Exclusion Criteria:

  • Any contra-indication to beta-blockers
  • Any Endoscopic Variceal Ligation or Sclerotherapy within last 3 months
  • High risk gastric varices
  • Any past history of Transhepatic Intrajugular Portosystemic Shunt or surgery for portal hypertension
  • Significant cardio or pulmonary co-morbidity
  • Any extrahepatic malignancy
  • Patients with past history of variceal bleed
  • Patients with non-tumor portal vein thrombosis
  • Refusal to participate in the study

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Endoscopic Variceal Ligation
Endoscopic Variceal Ligation every 3 weeks till eradication
Procedure: Endoscopic Variceal Ligation
Endoscopic Variceal Ligation every 3 weeks till eradication.
ACTIVE_COMPARATOR: Carvedilol
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
Drug: Carvedilol
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First Variceal Bleeding
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 1.5 years
1.5 years
Procedure related complications.
Time Frame: 1.5 years
1.5 years
Reappearance of Esophageal varices in presence of Portal Vein Thrombosis
Time Frame: 1.5 years
1.5 years

Collaborators and Investigators

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

Sponsor

Institute of Liver and Biliary Sciences, India

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

February 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

August 4, 2012

First Submitted That Met QC Criteria

August 4, 2012

First Posted (ESTIMATE)

August 7, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-HCC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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