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

NCT01659346 | Withdrawn

• 1 other identifier: ILBS-HCC-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma With Portal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• First Variceal Bleeding

  1.5 years

Secondary Outcomes (3)

• Death

  1.5 years

• Procedure related complications.

  1.5 years

• Reappearance of Esophageal varices in presence of Portal Vein Thrombosis

  1.5 years

Study Arms (2)

Endoscopic Variceal Ligation

EXPERIMENTAL

Endoscopic Variceal Ligation every 3 weeks till eradication

Procedure: Endoscopic Variceal Ligation

Carvedilol

ACTIVE COMPARATOR

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

Drug: Carvedilol

Interventions

Endoscopic Variceal Ligation PROCEDURE

Endoscopic Variceal Ligation every 3 weeks till eradication.

Endoscopic Variceal Ligation

Carvedilol DRUG

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

Carvedilol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Dr Shakti P Choudhury, MD

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2012
• First Posted: August 7, 2012
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-09

Locations

IN (1)