<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/NCT04471272</url>
  </required_header>
  <id_info>
    <org_study_id>H-1909-086-1064</org_study_id>
    <nct_id>NCT04471272</nct_id>
  </id_info>
  <brief_title>RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes</brief_title>
  <official_title>Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual RF Energy Delivery Mode With Octopus Electrodes: A Prospective Observational 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators intend to perform RFA therapy on HCC less than 4 cm in size using octopus&#xD;
      electrode, double alternating unipolar high-frequency transmission mode and gradual&#xD;
      high-frequency energy loading mode, and to find out the therapeutic results. The primary&#xD;
      evaluation variable is the ideal technical success rate for securing a safety margin of 5 mm&#xD;
      or more around the tumor on the CT obtained immediately after the procedure, and the&#xD;
      secondary evaluation variable is the volume of the cauterization lesion per unit time&#xD;
      measured on the CT obtained immediately after the procedure, The local tumor recurrence rate,&#xD;
      survival rate and disease-free survival rate of 12 months after the procedure, the presence&#xD;
      or absence of multiple recurrences within the same segment, the actual procedure time, and&#xD;
      the incidence of complications associated with the procedure are examined. The performance of&#xD;
      RFA therapy of HCC using the Octopus electrode and gradual high-frequency energy transfer&#xD;
      mode is compared with that of the existing Octopus electrode and RFA therapy using the basic&#xD;
      maximum high-frequency energy transfer mode using historic cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Pre-treatment planning:&#xD;
&#xD;
           The detailed plan of radio frequency ablation (RFA) will be implemented in accordance&#xD;
           with the routine procedure of image evaluation prior to high frequency implementation.&#xD;
           In other words, the location of the tumor on the Multiphasic CT or MRI and the RFA&#xD;
           planning program at the 3D workstation (Philips, Intraportal) before RFA procedure,&#xD;
           evaluate the tumor volume and the relationship with adjacent blood vessels, and insert&#xD;
           the electrode for RFA After planning the number of ablation and the like, the location&#xD;
           of the tumor in the ultrasound image was found in the pre-surgery image by fusion of the&#xD;
           pre-surgery image and the ultrasound image using US-CT-MR fusion and contrast-enhanced&#xD;
           ultrasonography, which are recently used. It will evaluate whether the tumors match, and&#xD;
           also evaluate whether the distribution of the echo bubble and the tumor position&#xD;
           coincide during the procedure in real time.&#xD;
&#xD;
           In addition, the degree of stiffness of the parenchyma will be measured by using an&#xD;
           ultrasound elastic technique. At this time, the ultrasonic fusion device to be used will&#xD;
           be one of Phillips, GE, or one of the navigation systems of Siemens, Canon, and Samsung,&#xD;
           available here. The fused image guides the location of the electrodes to be installed in&#xD;
           the tumor, the number of electrodes, and a safe access route. If the extent of the tumor&#xD;
           is not clearly visible, or the image before the procedure is too old (&gt; 6 weeks), low&#xD;
           kVp or DECT will be conducted to evaluate the tumor's extent more accurately.&#xD;
&#xD;
        2. RFA procedure As the equipment of RFA, the multi-VIVA generator and octopus electrode&#xD;
           used herein will be used. In the method of treatment, three high-frequency electrode&#xD;
           needles were placed on the tumor according to the clinical need under the guidance of&#xD;
           fusion ultrasound, and then the electrodes were cooled with saline, and the two&#xD;
           electrodes were simultaneously applied with high-frequency waves for approximately 6-30&#xD;
           minutes depending on the size of the tumor. The temperature is maintained at 90-100&#xD;
           degrees Celsius. At this time, the high-frequency energy is increased by 10W at 30W&#xD;
           intervals at 60Watt for the first 3 minutes, and then gradually increased by 10W per&#xD;
           minute after 100W.&#xD;
&#xD;
      The location of the tumor on the ultrasound image by fusion of the ultrasound image with the&#xD;
      pre-procedure using the US-CT-MR fusion tool (Navigator- GE, PercuNav-Phillips, Canon,&#xD;
      S-fusion: Samsung), which is frequently used in RFA procedures. It will evaluate whether the&#xD;
      tumors found in the images before the procedure match, and also evaluate whether the&#xD;
      distribution of the echo bubble and the tumor location coincide during the procedure in real&#xD;
      time. At this time, the navigation systems used by Samsung, Phillips, GE, and Canon will be&#xD;
      used as the ultrasonic fusion device to be used. In the Fusion US image, the Octopus&#xD;
      electrode is safely placed in the tumor through the access path of the electrode already&#xD;
      planned. Thereafter, while transmitting high-frequency energy, air bubbles are generated in&#xD;
      the tumor on the ultrasound image, and an echogenic cloud is formed while the procedure is&#xD;
      stopped when the echogenic cloud becomes larger than 5 mm than the tumor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 6, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Study population: RFA using gradual RF energy delivery mode with Octopus electrodes&#xD;
Control group: Over a period of two years from 2017 to 2018, the patients who performed RFA for HCC using octopus electrodes and the maximum high-frequency energy transfer mode technique were collected. After performing propensity score matching analysis using variables of liver function values, the same number of controls are selected and set.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ideal technical success rate</measure>
    <time_frame>Time: immediately</time_frame>
    <description>Secure a safety margin of 5 mm or more around the tumor on CT obtained immediately after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ablation volume</measure>
    <time_frame>Time: immediately</time_frame>
    <description>Volume of ablation lesions per unit time measured on CT obtained immediately after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence rate</measure>
    <time_frame>Time: 12months</time_frame>
    <description>Local recurrence rate of 12 months after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>Time: 3years</time_frame>
    <description>Survival rate after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>Time: 3years</time_frame>
    <description>disease-free survival rate after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Time: immediately</time_frame>
    <description>The incidence of complications associated with the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical time</measure>
    <time_frame>Time: immediately</time_frame>
    <description>The actual procedure time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Radiofrequency Ablation</condition>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>RFA using gradual RF energy delivery mode</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RFA therapy is performed on HCC less than 4 cm in size using an octopus electrode, a double-shift unipolar high-frequency transmission mode, and a gradual high-frequency energy loading mode.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFA using gradual RF energy delivery mode with Octopus electrodes</intervention_name>
    <description>RFA therapy is performed on HCC less than 4 cm in size using an octopus electrode, a double-shift unipolar high-frequency transmission mode, and a gradual high-frequency energy loading mode.</description>
    <arm_group_label>RFA using gradual RF energy delivery mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  agree to the protocol's requirements and submit a consent form&#xD;
&#xD;
          -  20 years old-85 years old&#xD;
&#xD;
          -  Child-Pugh Class A&#xD;
&#xD;
          -  among patients with chronic hepatitis or cirrhosis, MDCT or MRI hepatocellular&#xD;
             carcinoma of less than 4 cm in size was suspected, and was referred to the radiology&#xD;
             department considering clinical RFA therapy as a clinical judgment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  when the number of malignant HCC is 3 or more&#xD;
&#xD;
          -  if the tumor has a maximum size of more than 4 cm&#xD;
&#xD;
          -  diffuse infiltrative HCC&#xD;
&#xD;
          -  Child-Pugh class B or C&#xD;
&#xD;
          -  If there is an invasion of liver vessels due to malignant HCC&#xD;
&#xD;
          -  severe coagulopathy&#xD;
&#xD;
          -  multiple distant metastasis&#xD;
&#xD;
          -  situations where it is very unlikely to obtain appropriate data for research purposes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jeong Min Lee, MD, PhD</last_name>
    <phone>+82-2072-3107</phone>
    <email>jmlshy2000@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SAE JIN PARK, MD</last_name>
      <phone>82220723107</phone>
      <email>psjko05@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jeong Min Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>March 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</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>
  <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/NCT04471272
org study id: H-1909-086-1064
nct id: NCT04471272
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators intend to perform RFA therapy on HCC less than 4 cm in size using octopus
      electrode, double alternating unipolar high-frequency transmission mode and gradual
      high-frequency energy loading mode, and to find out the therapeutic results. The primary
      evaluation variable is the ideal technical success rate for securing a safety margin of 5 mm
      or more around the tumor on the CT obtained immediately after the procedure, and the
      secondary evaluation variable is the volume of the cauterization lesion per unit time
      measured on the CT obtained immediately after the procedure, The local tumor recurrence rate,
      survival rate and disease-free survival rate of 12 months after the procedure, the presence
      or absence of multiple recurrences within the same segment, the actual procedure time, and
      the incidence of complications associated with the procedure are examined. The performance of
      RFA therapy of HCC using the Octopus electrode and gradual high-frequency energy transfer
      mode is compared with that of the existing Octopus electrode and RFA therapy using the basic
      maximum high-frequency energy transfer mode using historic cohort.
1. Pre-treatment planning:

           The detailed plan of radio frequency ablation (RFA) will be implemented in accordance
           with the routine procedure of image evaluation prior to high frequency implementation.
           In other words, the location of the tumor on the Multiphasic CT or MRI and the RFA
           planning program at the 3D workstation (Philips, Intraportal) before RFA procedure,
           evaluate the tumor volume and the relationship with adjacent blood vessels, and insert
           the electrode for RFA After planning the number of ablation and the like, the location
           of the tumor in the ultrasound image was found in the pre-surgery image by fusion of the
           pre-surgery image and the ultrasound image using US-CT-MR fusion and contrast-enhanced
           ultrasonography, which are recently used. It will evaluate whether the tumors match, and
           also evaluate whether the distribution of the echo bubble and the tumor position
           coincide during the procedure in real time.

           In addition, the degree of stiffness of the parenchyma will be measured by using an
           ultrasound elastic technique. At this time, the ultrasonic fusion device to be used will
           be one of Phillips, GE, or one of the navigation systems of Siemens, Canon, and Samsung,
           available here. The fused image guides the location of the electrodes to be installed in
           the tumor, the number of electrodes, and a safe access route. If the extent of the tumor
           is not clearly visible, or the image before the procedure is too old (> 6 weeks), low
           kVp or DECT will be conducted to evaluate the tumor's extent more accurately.

        2. RFA procedure As the equipment of RFA, the multi-VIVA generator and octopus electrode
           used herein will be used. In the method of treatment, three high-frequency electrode
           needles were placed on the tumor according to the clinical need under the guidance of
           fusion ultrasound, and then the electrodes were cooled with saline, and the two
           electrodes were simultaneously applied with high-frequency waves for approximately 6-30
           minutes depending on the size of the tumor. The temperature is maintained at 90-100
           degrees Celsius. At this time, the high-frequency energy is increased by 10W at 30W
           intervals at 60Watt for the first 3 minutes, and then gradually increased by 10W per
           minute after 100W.

      The location of the tumor on the ultrasound image by fusion of the ultrasound image with the
      pre-procedure using the US-CT-MR fusion tool (Navigator- GE, PercuNav-Phillips, Canon,
      S-fusion: Samsung), which is frequently used in RFA procedures. It will evaluate whether the
      tumors found in the images before the procedure match, and also evaluate whether the
      distribution of the echo bubble and the tumor location coincide during the procedure in real
      time. At this time, the navigation systems used by Samsung, Phillips, GE, and Canon will be
      used as the ultrasonic fusion device to be used. In the Fusion US image, the Octopus
      electrode is safely placed in the tumor through the access path of the electrode already
      planned. Thereafter, while transmitting high-frequency energy, air bubbles are generated in
      the tumor on the ultrasound image, and an echogenic cloud is formed while the procedure is
      stopped when the echogenic cloud becomes larger than 5 mm than the tumor.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Study population: RFA using gradual RF energy delivery mode with Octopus electrodes
Control group: Over a period of two years from 2017 to 2018, the patients who performed RFA for HCC using octopus electrodes and the maximum high-frequency energy transfer mode technique were collected. After performing propensity score matching analysis using variables of liver function values, the same number of controls are selected and set.
primary purpose: Treatment
masking: None (Open Label)
measure: Ideal technical success rate
time frame: Time: immediately
description: Secure a safety margin of 5 mm or more around the tumor on CT obtained immediately after the procedure
measure: Ablation volume
time frame: Time: immediately
description: Volume of ablation lesions per unit time measured on CT obtained immediately after the procedure
measure: Local recurrence rate
time frame: Time: 12months
description: Local recurrence rate of 12 months after the procedure
measure: Overall survival rate
time frame: Time: 3years
description: Survival rate after the procedure
measure: Disease free survival
time frame: Time: 3years
description: disease-free survival rate after the procedure
measure: Complication rate
time frame: Time: immediately
description: The incidence of complications associated with the procedure
measure: Technical time
time frame: Time: immediately
description: The actual procedure time
arm group label: RFA using gradual RF energy delivery mode
arm group type: Experimental
description: RFA therapy is performed on HCC less than 4 cm in size using an octopus electrode, a double-shift unipolar high-frequency transmission mode, and a gradual high-frequency energy loading mode.
intervention type: Procedure
intervention name: RFA using gradual RF energy delivery mode with Octopus electrodes
description: RFA therapy is performed on HCC less than 4 cm in size using an octopus electrode, a double-shift unipolar high-frequency transmission mode, and a gradual high-frequency energy loading mode.
arm group label: RFA using gradual RF energy delivery mode
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jeong Min Lee, MD, PhD
phone: +82-2072-3107
email: jmlshy2000@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
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