We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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This study has been withdrawn prior to enrollment.
(Due to high mortality)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659346
First Posted: August 7, 2012
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Death [ Time Frame: 1.5 years ]
  • Procedure related complications. [ Time Frame: 1.5 years ]
  • Reappearance of Esophageal varices in presence of Portal Vein Thrombosis [ Time Frame: 1.5 years ]

Enrollment: 0
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659346


Locations
India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
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
First Submitted: August 4, 2012
First Posted: August 7, 2012
Last Update Posted: November 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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