Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 currently recruiting participants. (see Contacts and Locations)
Verified August 2016 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: August 26, 2016
Last verified: August 2016
  Purpose
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.

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: 1.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • Procedure related complications. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • Reappearance of Esophageal varices in presence of Portal Vein Thrombosis [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: February 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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   (Adult)
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 Shakti P Choudhury, MD 011-46300000 shakti784@gmail.com

Locations
India
Institute of Liver and Biliary Sciences 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 Shakti P Choudhury, MD Institute of Liver and Biliary Sciences
  More Information

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: August 26, 2016
Health Authority: India: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Thrombosis
Venous Thrombosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on December 02, 2016