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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01659346

Enrollment

Registered

2012-08-07

Start date

2016-02-29

Completion date

2017-12-31

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma With Portal Vein Thrombosis

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.

Interventions

PROCEDUREEndoscopic Variceal Ligation

Endoscopic Variceal Ligation every 3 weeks till eradication.

DRUGCarvedilol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
First Variceal Bleeding	1.5 years

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026