Back to resultsNon-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.
Primary Purpose
Hepatocellular Carcinoma With Portal Vein Thrombosis
Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Endoscopic Variceal Ligation
Carvedilol
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma With Portal Vein Thrombosis
Eligibility 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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endoscopic Variceal Ligation
Carvedilol
Arm Description
Endoscopic Variceal Ligation every 3 weeks till eradication
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
Outcomes
Primary Outcome Measures
First Variceal Bleeding
Secondary Outcome Measures
Death
Procedure related complications.
Reappearance of Esophageal varices in presence of Portal Vein Thrombosis
Full Information
NCT ID
NCT01659346
First Posted
August 4, 2012
Last Updated
November 14, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT01659346
Brief Title
Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Due to high mortality
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma With Portal Vein Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Variceal Ligation
Arm Type
Experimental
Arm Description
Endoscopic Variceal Ligation every 3 weeks till eradication
Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Description
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Variceal Ligation
Intervention Description
Endoscopic Variceal Ligation every 3 weeks till eradication.
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
Primary Outcome Measure Information:
Title
First Variceal Bleeding
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Death
Time Frame
1.5 years
Title
Procedure related complications.
Time Frame
1.5 years
Title
Reappearance of Esophageal varices in presence of Portal Vein Thrombosis
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Shakti P Choudhury, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.
We'll reach out to this number within 24 hrs