Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis
Primary Purpose
Hepatocellular Carcinoma (HCC)
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
transarterial chemoembolization versus the standard treatment with sorafinib
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma (HCC)
Eligibility Criteria
Inclusion Criteria:
- Patients with newly diagnosed HCC,
- Child class A and
- Portal vein branch tumoral thrombus (proved by imaging)
- written informed consent
Exclusion Criteria:
- patients with Child class B and C,
- main Portal vein thrombosis,
- previous management for HCC,
- Arterio-portal shunt
- refused to be enrolled
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCC patients with Pranch portal vein thrombosis
Arm Description
Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.
Outcomes
Primary Outcome Measures
changes in Radiological Response in the (CT/ MRI) after the intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT03007212
First Posted
December 24, 2016
Last Updated
December 29, 2016
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03007212
Brief Title
Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess the outcomes after TACE in patients with branch PVT regarding Child classification, radiological response and 1 year survival.
Detailed Description
Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCC patients with Pranch portal vein thrombosis
Arm Type
Experimental
Arm Description
Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.
Intervention Type
Procedure
Intervention Name(s)
transarterial chemoembolization versus the standard treatment with sorafinib
Intervention Description
TACE procedures were performed by the interventional radiologist through femoral artery approach in all patients. Super-selective cannulation of the main feeders was performed using a microcatheter whenever possible. The c-TACE protocol consisted of intra-arterial infusion of cisplatin 50-100 mg mixed with lipiodol ,Just prior to injection, emulsion is prepared by intensive mixing of equal volumes of cytotoxic drug solution and iodized oil using the pumping method with two syringes and a three way stop cock. Injection is guided by fluoroscopy and results in dense accumulation of the emulsion within the tumor vascular bed. Injection of poor iodized oil up to a maximum volume of 10-20 cc is an option and is followed by embolization of feeding arteries by Gelfoam cubes .Endpoints of conventional TACE are complete filling of the tumor vascular bed with iodized oil and stop-flow in subsegmental and segmental feeding arteries..
Primary Outcome Measure Information:
Title
changes in Radiological Response in the (CT/ MRI) after the intervention
Time Frame
1 year
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 with newly diagnosed HCC,
Child class A and
Portal vein branch tumoral thrombus (proved by imaging)
written informed consent
Exclusion Criteria:
patients with Child class B and C,
main Portal vein thrombosis,
previous management for HCC,
Arterio-portal shunt
refused to be enrolled
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis
We'll reach out to this number within 24 hrs