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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01659346
First received: August 4, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

Every patient with HCC with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomised 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.


Condition Intervention
Hepatocellular Carcinoma With Portal Vein Thrombosis
Procedure: Endoscopic Variceal Ligation
Drug: Carvedilol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • First Variceal Bleeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Procedure related complications. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Reduction of risk of bleeding by 50 % [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic Variceal Ligation
Endoscopic Variceal Ligation every 3 weeks till eradication
Procedure: Endoscopic Variceal Ligation
Endoscopic Variceal Ligation every 3 weeks till eradication.
Active Comparator: Carvedilol
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
Drug: Carvedilol
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659346

Contacts
Contact: Dr SM Shasthry, MD 011-46300000 shasthry@gmail.com
Contact: Dr Ankit Bhardwaj 011-46300000 ext 1032 bhardwaj.ankit3@gmail.com

Locations
India
Institute of Liver and Biliary Sciences Not yet recruiting
New Delhi, Delhi, India, 110070
Contact: Dr SM Shasthry, MD    011-46300000    shasthry@gmail.com   
Contact: Dr Ankit Bhardwaj    011-46300000 ext 1032    bhardwaj.ankit3@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr SM Shasthry, MD Institute of Liver and Biliary Sciences
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01659346     History of Changes
Other Study ID Numbers: ILBS-HCC-01
Study First Received: August 4, 2012
Last Updated: December 16, 2013
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Hemorrhage
Thrombosis
Venous Thrombosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adrenergic beta-Antagonists
Carvedilol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on August 01, 2014