ClinicalTrials.Veeva

Menu

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

I

Institute of Liver and Biliary Sciences, India

Status

Withdrawn

Conditions

Hepatocellular Carcinoma With Portal Vein Thrombosis

Treatments

Procedure: Endoscopic Variceal Ligation
Drug: Carvedilol

Study type

Interventional

Funder types

Other

Identifiers

NCT01659346
ILBS-HCC-01

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Endoscopic Variceal Ligation
Experimental group
Description:
Endoscopic Variceal Ligation every 3 weeks till eradication
Treatment:
Procedure: Endoscopic Variceal Ligation
Carvedilol
Active Comparator group
Description:
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
Treatment:
Drug: Carvedilol

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems