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
N/A
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Hepatocellular Carcinoma With Portal Vein Thrombosis
Both
Hepatocellular Carcinoma With Portal Vein Thrombosis
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
First Variceal Bleeding
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Dr SM Shasthry, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institute of Liver and Biliary Sciences
Authority:
India: Institutional Review Board
Study ID:
ILBS-HCC-01
NCT ID:
NCT01659346
Start Date:
August 2012
Completion Date:
August 2014
Related Keywords:
- Hepatocellular Carcinoma With Portal Vein Thrombosis
- Carcinoma
- Hemorrhage
- Thrombosis
- Venous Thrombosis
- Carcinoma, Hepatocellular
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