<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/NCT03806218</url>
  </required_header>
  <id_info>
    <org_study_id>SNUH-2015-0401</org_study_id>
    <nct_id>NCT03806218</nct_id>
  </id_info>
  <brief_title>Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC</brief_title>
  <official_title>Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to provide preliminary data for the main trial to compare efficacy&#xD;
      between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and&#xD;
      switching monopolar RFA using separable clustered electrodes in the treatment of recurrent&#xD;
      hepatocellular carcinoma (HCC) after locoregional treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2015</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2018</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Minimum diameter of ablation zone per unit time</measure>
    <time_frame>3 days after RFA</time_frame>
    <description>Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technique efficacy</measure>
    <time_frame>1 month after RFA</time_frame>
    <description>Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IDR rate</measure>
    <time_frame>12 months, 24 months after RFA</time_frame>
    <description>Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EM rate</measure>
    <time_frame>12 months, 24 months after RFA</time_frame>
    <description>Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local tumor progression (LTP)</measure>
    <time_frame>12 months, 24 months after RFA</time_frame>
    <description>Cumulative LTP rates in two groups in 2 years after RFA</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complication</measure>
    <time_frame>1 month after RFA</time_frame>
    <description>Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.</description>
  </other_outcome>
  <other_outcome>
    <measure>Volume of ablative zone</measure>
    <time_frame>3 days after RFA</time_frame>
    <description>Volume of ablative zone on post-RFA CT or MRI in a mm3</description>
  </other_outcome>
  <other_outcome>
    <measure>Ablation time</measure>
    <time_frame>1 day</time_frame>
    <description>RFA procedure time in each patient.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>TICW-RFA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bipolar RFA using twin internally cooled-wet electrodes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SC-RFA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Switching monopolar RFA using separable clustered electrodes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bipolar RFA</intervention_name>
    <description>Bipolar RFA in which RF currents flow between two electrodes</description>
    <arm_group_label>TICW-RFA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SM-RFA</intervention_name>
    <description>Monopolar RFA using multiple electrodes with switching mode</description>
    <arm_group_label>SC-RFA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Twin internally cooled-wet electrodes</intervention_name>
    <description>Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity</description>
    <arm_group_label>TICW-RFA</arm_group_label>
    <other_name>CWTN-T</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Separable clustered electrodes</intervention_name>
    <description>A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.</description>
    <arm_group_label>SC-RFA</arm_group_label>
    <other_name>Octopus®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment&#xD;
&#xD;
          -  HCC nodules measuring 1 cm or larger and smaller than 5 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  more than three HCC nodules&#xD;
&#xD;
          -  tumors with major vascular invasion or abutment to the central portal or hepatic vein&#xD;
             with a diameter &gt; 5mm&#xD;
&#xD;
          -  extrahepatic metastasis&#xD;
&#xD;
          -  Child-Pugh class C&#xD;
&#xD;
          -  severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin&#xD;
             time international normalized ratio (PT-INR) prolongation of more than 50 %)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Min Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>April 3, 2020</last_update_submitted>
  <last_update_submitted_qc>April 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong Min Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>RFA</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>No</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/NCT03806218
org study id: SNUH-2015-0401
nct id: NCT03806218
lead sponsor: 
has dmc: Yes
This study was conducted to provide preliminary data for the main trial to compare efficacy
      between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and
      switching monopolar RFA using separable clustered electrodes in the treatment of recurrent
      hepatocellular carcinoma (HCC) after locoregional treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Minimum diameter of ablation zone per unit time
time frame: 3 days after RFA
description: Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.
measure: Technique efficacy
time frame: 1 month after RFA
description: Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
measure: IDR rate
time frame: 12 months, 24 months after RFA
description: Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA
measure: EM rate
time frame: 12 months, 24 months after RFA
description: Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA
measure: Local tumor progression (LTP)
time frame: 12 months, 24 months after RFA
description: Cumulative LTP rates in two groups in 2 years after RFA
measure: Complication
time frame: 1 month after RFA
description: Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.
measure: Volume of ablative zone
time frame: 3 days after RFA
description: Volume of ablative zone on post-RFA CT or MRI in a mm3
measure: Ablation time
time frame: 1 day
description: RFA procedure time in each patient.
arm group label: TICW-RFA
arm group type: Active Comparator
description: Bipolar RFA using twin internally cooled-wet electrodes
arm group label: SC-RFA
arm group type: Active Comparator
description: Switching monopolar RFA using separable clustered electrodes
intervention type: Device
intervention name: Bipolar RFA
description: Bipolar RFA in which RF currents flow between two electrodes
arm group label: TICW-RFA
intervention type: Device
intervention name: SM-RFA
description: Monopolar RFA using multiple electrodes with switching mode
arm group label: SC-RFA
intervention type: Device
intervention name: Twin internally cooled-wet electrodes
description: Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity
arm group label: TICW-RFA
other name: CWTN-T
intervention type: Device
intervention name: Separable clustered electrodes
description: A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
arm group label: SC-RFA
other name: Octopus®
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jeong Min Lee, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong Min Lee
investigator title: Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No