<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/NCT03807947</url>
  </required_header>
  <id_info>
    <org_study_id>ICHRadialTAE</org_study_id>
    <nct_id>NCT03807947</nct_id>
  </id_info>
  <brief_title>Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma</brief_title>
  <official_title>Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humanitas Clinical and Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Humanitas Clinical and Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective, randomized study is to compare TRA vs TFA for superselective&#xD;
      embolization of HCC using bland microparticles performed by multiple operators.&#xD;
&#xD;
      In particular, main objectives are to compare:&#xD;
&#xD;
        1. the success rates of TRA and TFA including crossing over events between techniques&#xD;
&#xD;
        2. the inter-operator outcomes in terms of time to complete the vascular access and the&#xD;
           vessel catheterization&#xD;
&#xD;
        3. access-related adverse events&#xD;
&#xD;
        4. patient preference and reported discomfort&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatic arterial chemoembolization is a safe, proven, and effective technique for the&#xD;
      treatment of a number of malignancies, including primary and secondary tumors [1, 2]. This&#xD;
      endovascular treatment is performed via femoral artery access in most cases. In the last&#xD;
      decades, the transradial approach (TRA) has emerged as a valid alternative to the&#xD;
      transfemoral approach (TFA), and it is commonly used in coronary angioplasty as well as stent&#xD;
      placement. In particular, shorter monitoring time after the procedure, earlier ambulation,&#xD;
      shorter hospital stay and less discomfort associated with potentially reduced bleeding risks&#xD;
      make TRA an attractive alternative to TFA.&#xD;
&#xD;
      To date, only one study exists comparing TRA vs TFA in liver embolizations [3]. However, it&#xD;
      is non-randomized and reports only the outcomes of one operator performing lobar embolization&#xD;
      for multiple liver malignancies.&#xD;
&#xD;
      The aim of this prospective, randomized study is to compare TRA vs TFA for superselective&#xD;
      embolization of HCC using bland microparticles performed by multiple operators.&#xD;
&#xD;
      In particular, main objectives are to compare:&#xD;
&#xD;
        1. the success rates of TRA and TFA including crossing over events between techniques&#xD;
&#xD;
        2. the inter-operator outcomes in terms of time to complete the vascular access and the&#xD;
           vessel catheterization&#xD;
&#xD;
        3. access-related adverse events&#xD;
&#xD;
        4. patient preference and reported discomfort&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain and discomfort during and after procedures</measure>
    <time_frame>24 hours after intervention</time_frame>
    <description>Questionnaire with four questions with 5 a points scale describing pain and discomfort during and after procedure, where 0 is the minimum and 4 the maximum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Access-related adverse events</measure>
    <time_frame>0-48h after intervention.</time_frame>
    <description>Complication at the site of access like hematoma or pseudoaneurysm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Hepatocellular Carcinoma Non-resectable</condition>
  <arm_group>
    <arm_group_label>Radial access</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Transfemoral Access</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radial TAE - Bland embolization with 40-100 Microparticles</intervention_name>
    <description>TAE - Bland embolization with 40-100 Microparticles performed via left transradial access</description>
    <arm_group_label>Radial access</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transfemoral TAE - Bland embolization with 40-100 Microparticles</intervention_name>
    <description>TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access</description>
    <arm_group_label>Transfemoral Access</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  patients affected by HCC with indication to TAE from a multidisciplinary team&#xD;
             discussion.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  TAE for other malignancies or bleedings;&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>EZIO LANZA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Iezzi R, Pompili M, Posa A, Annicchiarico E, Garcovich M, Merlino B, Rodolfino E, Di Noia V, Basso M, Cassano A, Barone C, Gasbarrini A, Manfredi R, Colosimo C. Transradial versus Transfemoral Access for Hepatic Chemoembolization: Intrapatient Prospective Single-Center Study. J Vasc Interv Radiol. 2017 Sep;28(9):1234-1239. doi: 10.1016/j.jvir.2017.06.022. Epub 2017 Jul 27.</citation>
    <PMID>28757286</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>embolisation, therapeutic</keyword>
  <keyword>Embolization, Therapeutic</keyword>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>HCC</keyword>
  <keyword>TAE</keyword>
  <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/NCT03807947
org study id: ICHRadialTAE
nct id: NCT03807947
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this prospective, randomized study is to compare TRA vs TFA for superselective
      embolization of HCC using bland microparticles performed by multiple operators.

      In particular, main objectives are to compare:

        1. the success rates of TRA and TFA including crossing over events between techniques

        2. the inter-operator outcomes in terms of time to complete the vascular access and the
           vessel catheterization

        3. access-related adverse events

        4. patient preference and reported discomfort
Hepatic arterial chemoembolization is a safe, proven, and effective technique for the
      treatment of a number of malignancies, including primary and secondary tumors [1, 2]. This
      endovascular treatment is performed via femoral artery access in most cases. In the last
      decades, the transradial approach (TRA) has emerged as a valid alternative to the
      transfemoral approach (TFA), and it is commonly used in coronary angioplasty as well as stent
      placement. In particular, shorter monitoring time after the procedure, earlier ambulation,
      shorter hospital stay and less discomfort associated with potentially reduced bleeding risks
      make TRA an attractive alternative to TFA.

      To date, only one study exists comparing TRA vs TFA in liver embolizations [3]. However, it
      is non-randomized and reports only the outcomes of one operator performing lobar embolization
      for multiple liver malignancies.

      The aim of this prospective, randomized study is to compare TRA vs TFA for superselective
      embolization of HCC using bland microparticles performed by multiple operators.

      In particular, main objectives are to compare:

        1. the success rates of TRA and TFA including crossing over events between techniques

        2. the inter-operator outcomes in terms of time to complete the vascular access and the
           vessel catheterization

        3. access-related adverse events

        4. patient preference and reported discomfort
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain and discomfort during and after procedures
time frame: 24 hours after intervention
description: Questionnaire with four questions with 5 a points scale describing pain and discomfort during and after procedure, where 0 is the minimum and 4 the maximum.
measure: Access-related adverse events
time frame: 0-48h after intervention.
description: Complication at the site of access like hematoma or pseudoaneurysm
arm group label: Radial access
arm group type: Experimental
arm group label: Transfemoral Access
arm group type: Active Comparator
intervention type: Procedure
intervention name: Radial TAE - Bland embolization with 40-100 Microparticles
description: TAE - Bland embolization with 40-100 Microparticles performed via left transradial access
arm group label: Radial access
intervention type: Procedure
intervention name: Transfemoral TAE - Bland embolization with 40-100 Microparticles
description: TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access
arm group label: Transfemoral Access
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: EZIO LANZA, MD
role: Principal Investigator
affiliation: Humanitas Research Hospital
facility: 
country: Italy
citation: Iezzi R, Pompili M, Posa A, Annicchiarico E, Garcovich M, Merlino B, Rodolfino E, Di Noia V, Basso M, Cassano A, Barone C, Gasbarrini A, Manfredi R, Colosimo C. Transradial versus Transfemoral Access for Hepatic Chemoembolization: Intrapatient Prospective Single-Center Study. J Vasc Interv Radiol. 2017 Sep;28(9):1234-1239. doi: 10.1016/j.jvir.2017.06.022. Epub 2017 Jul 27.
PMID: 28757286
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided