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

Hepatocellular Carcinoma With Portal Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01659346
• Other study ID #: ILBS-HCC-01
• Status: Withdrawn
• Phase: N/A
• First received: August 4, 2012
• Last updated: November 14, 2017
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma With Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Endoscopic Variceal Ligation
Endoscopic Variceal Ligation every 3 weeks till eradication.

Drug:
• Carvedilol
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Variceal Bleeding		1.5 years
Secondary	Death		1.5 years
Secondary	Procedure related complications.		1.5 years
Secondary	Reappearance of Esophageal varices in presence of Portal Vein Thrombosis		1.5 years