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RFA for Small HCC With No-touch Technique Using Octopus Electrode

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No-touch RFA
Conventional tumor puncture RFA
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HCC, RFA

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child-Pugh class A
  • patient with 1cm-2.5cm sized HCC
  • 1 or 2 HCCs
  • being referred for curative purpose of RFA
  • sign informed consent

Exclusion Criteria:

  • maximum tumor diameter greater than 2.5cm
  • Child-Pugh class B or C
  • more than 3 HCC lesions
  • invisible tumor even after US/CT or US/MR fusion
  • presence of vascular tumor thrombosis or extrahepatic metastasis
  • severe coagulopathy (PLT < 50K, PT < 50% of normal range)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    No-touch RFA arm

    Conventional tumor puncture RFA arm

    Arm Description

    No-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique.

    Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique.

    Outcomes

    Primary Outcome Measures

    12 month local tumor progression (LTP) rate

    Secondary Outcome Measures

    tumor seeding rate
    incidence of tract seeding after RFA.
    Complication rate related with RFA
    RFA-related complication rate such as death, abscess, bleeding..etc.
    Technical success rate
    presence or absence of residual lesion on follow-up imaging

    Full Information

    First Posted
    June 3, 2016
    Last Updated
    March 17, 2021
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02832882
    Brief Title
    RFA for Small HCC With No-touch Technique Using Octopus Electrode
    Official Title
    Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 21, 2016 (Actual)
    Primary Completion Date
    September 11, 2018 (Actual)
    Study Completion Date
    January 17, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Hepatocellular
    Keywords
    HCC, RFA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No-touch RFA arm
    Arm Type
    Experimental
    Arm Description
    No-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique.
    Arm Title
    Conventional tumor puncture RFA arm
    Arm Type
    Active Comparator
    Arm Description
    Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique.
    Intervention Type
    Procedure
    Intervention Name(s)
    No-touch RFA
    Intervention Description
    No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional tumor puncture RFA
    Intervention Description
    Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.
    Primary Outcome Measure Information:
    Title
    12 month local tumor progression (LTP) rate
    Time Frame
    12 month after RFA
    Secondary Outcome Measure Information:
    Title
    tumor seeding rate
    Description
    incidence of tract seeding after RFA.
    Time Frame
    12 months after RFA
    Title
    Complication rate related with RFA
    Description
    RFA-related complication rate such as death, abscess, bleeding..etc.
    Time Frame
    1 month
    Title
    Technical success rate
    Description
    presence or absence of residual lesion on follow-up imaging
    Time Frame
    1 months
    Other Pre-specified Outcome Measures:
    Title
    Ablation time
    Description
    ablation time for tumor ablation
    Time Frame
    3 days after RFA
    Title
    Intrahepatic distant mets
    Description
    incidence of intrahepatic distant metastasis after RFA
    Time Frame
    12 months after RFA
    Title
    Extrahepatic distant mets
    Description
    incidence of extrahepatic distant metastasis after RFA
    Time Frame
    12 months after RFA
    Title
    Technical efficacy 1
    Description
    Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using visual assessment
    Time Frame
    2 days after RFA
    Title
    Technical efficacy 2
    Description
    Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using registration software
    Time Frame
    2 days after RFA

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Child-Pugh class A patient with 1cm-2.5cm sized HCC 1 or 2 HCCs being referred for curative purpose of RFA sign informed consent Exclusion Criteria: maximum tumor diameter greater than 2.5cm Child-Pugh class B or C more than 3 HCC lesions invisible tumor even after US/CT or US/MR fusion presence of vascular tumor thrombosis or extrahepatic metastasis severe coagulopathy (PLT < 50K, PT < 50% of normal range)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeong Min Lee, MD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    RFA for Small HCC With No-touch Technique Using Octopus Electrode

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