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

Not Applicable

Withdrawn

• Conditions: Hepatocellular Carcinoma With Portal Vein Thrombosis
• Interventions: Procedure: Endoscopic Variceal Ligation; Drug: Carvedilol

• Registration Number: NCT01659346
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-04
• Study First Submitted QC: 2012-08-04
• Study First Posted: 2012-08-07
• Study Start: 2016-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Variceal Ligation	Endoscopic Variceal Ligation	Endoscopic Variceal Ligation every 3 weeks till eradication
Carvedilol	Carvedilol	Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD

Primary Outcome Measures

Name	Time	Method
First Variceal Bleeding	1.5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India