- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007212
Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis
December 29, 2016 updated by: Iman Fawzy Montasser, Ain Shams University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HCC patients with Pranch portal vein thrombosis
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.
|
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..
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in Radiological Response in the (CT/ MRI) after the intervention
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
December 24, 2016
First Submitted That Met QC Criteria
December 29, 2016
First Posted (Estimate)
January 2, 2017
Study Record Updates
Last Update Posted (Estimate)
January 2, 2017
Last Update Submitted That Met QC Criteria
December 29, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hepatocellular carcinoma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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