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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 24, 2016
    Last Updated
    December 29, 2016
    Sponsor
    Ain Shams University
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    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

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    Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis

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