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

NCT ID: NCT01659346

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma With Portal Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Variceal Ligation

Endoscopic Variceal Ligation every 3 weeks till eradication

Group Type EXPERIMENTAL

Endoscopic Variceal Ligation

Intervention Type PROCEDURE

Endoscopic Variceal Ligation every 3 weeks till eradication.

Carvedilol

Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD

Interventions

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Endoscopic Variceal Ligation

Endoscopic Variceal Ligation every 3 weeks till eradication.

Intervention Type PROCEDURE

Carvedilol

Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Shakti P Choudhury, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-HCC-01

Identifier Type: -

Identifier Source: org_study_id