<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03007212</url>
  </required_header>
  <id_info>
    <org_study_id>Hepatocellular Carcinoma</org_study_id>
    <nct_id>NCT03007212</nct_id>
  </id_info>
  <brief_title>Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess&#xD;
      the outcomes after TACE in patients with branch PVT regarding Child classification,&#xD;
      radiological response and 1 year survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was&#xD;
      done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory&#xD;
      investigations including liver function tests to assess deterioration in liver functions,&#xD;
      triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival&#xD;
      analysis was performed using Kaplan-Meier estimations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in Radiological Response in the (CT/ MRI) after the intervention</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hepatocellular Carcinoma (HCC)</condition>
  <arm_group>
    <arm_group_label>HCC patients with Pranch portal vein thrombosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transarterial chemoembolization versus the standard treatment with sorafinib</intervention_name>
    <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..</description>
    <arm_group_label>HCC patients with Pranch portal vein thrombosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly diagnosed HCC,&#xD;
&#xD;
          -  Child class A and&#xD;
&#xD;
          -  Portal vein branch tumoral thrombus (proved by imaging)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with Child class B and C,&#xD;
&#xD;
          -  main Portal vein thrombosis,&#xD;
&#xD;
          -  previous management for HCC,&#xD;
&#xD;
          -  Arterio-portal shunt&#xD;
&#xD;
          -  refused to be enrolled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Iman Fawzy Montasser</investigator_full_name>
    <investigator_title>Associate professor of tropical medicine , Ain Shams university</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03007212
org study id: Hepatocellular Carcinoma
nct id: NCT03007212
lead sponsor: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes in Radiological Response in the (CT/ MRI) after the intervention
time frame: 1 year
arm group label: HCC patients with Pranch portal vein thrombosis
arm group type: Experimental
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: transarterial chemoembolization versus the standard treatment with sorafinib
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..
arm group label: HCC patients with Pranch portal vein thrombosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Iman Fawzy Montasser
investigator title: Associate professor of tropical medicine , Ain Shams university
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided