Radiofrequency Ablation Using Cooled-Wet Electrode
Primary Purpose
HCC, Metastasis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cooled-wet electrode
separable clustered electrode
Sponsored by
About this trial
This is an interventional treatment trial for HCC focused on measuring RFA
Eligibility Criteria
Inclusion Criteria: all conditions have to be fulfilled.
- Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
- liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
- signed informed consent
- treatment naive index tumor (no history of local treatment for an index tumor)
Exclusion Criteria:
- more than three tumors in a patients
- tumor size larger than 5cm
- tumor attaches to central portal vein or hepatic vein
- Child-Pugh classification C
- uncorrected coagulopathy
- presence of extrahepatic metastases
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
RFA with cooled-wet electrode
RFA with separable clustered electrode
Arm Description
RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.
RFA using separable clustered electrode in switching monopolar mode under the fused US guidance
Outcomes
Primary Outcome Measures
LTP
cumulating local tumor progression rate over 2- year after RFA
Secondary Outcome Measures
Technical success rate
technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)
IDR rate
cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA
EM rate
cumulating extrahepatic metastasis (EM) rate over 2- year after RFA
Maximal diameter of ablative zone
Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
ablation time
RFA procedure time in each patient.
Complication
all complication rate and grades (according to Clavien system from I to III) related with RFA procedure
Volume of ablative zone
Volume of ablative zone on post-RFA CT or MRI in a mm3.
Full Information
NCT ID
NCT02675894
First Posted
February 1, 2016
Last Updated
March 17, 2021
Sponsor
Seoul National University Hospital
Collaborators
RF medical, Medical Research Collaborating Center
1. Study Identification
Unique Protocol Identification Number
NCT02675894
Brief Title
Radiofrequency Ablation Using Cooled-Wet Electrode
Official Title
Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2014 (Actual)
Primary Completion Date
January 19, 2017 (Actual)
Study Completion Date
April 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
RF medical, Medical Research Collaborating Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.
Detailed Description
To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC, Metastasis
Keywords
RFA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA with cooled-wet electrode
Arm Type
Active Comparator
Arm Description
RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.
Arm Title
RFA with separable clustered electrode
Arm Type
Active Comparator
Arm Description
RFA using separable clustered electrode in switching monopolar mode under the fused US guidance
Intervention Type
Device
Intervention Name(s)
cooled-wet electrode
Intervention Description
RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.
Intervention Type
Device
Intervention Name(s)
separable clustered electrode
Other Intervention Name(s)
Octopus(R)
Intervention Description
RFA is performed using separable clustered electrode in switching monopolar mode.
Primary Outcome Measure Information:
Title
LTP
Description
cumulating local tumor progression rate over 2- year after RFA
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)
Time Frame
1 months
Title
IDR rate
Description
cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA
Time Frame
24 months
Title
EM rate
Description
cumulating extrahepatic metastasis (EM) rate over 2- year after RFA
Time Frame
24 months
Title
Maximal diameter of ablative zone
Description
Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
Time Frame
7 day
Title
ablation time
Description
RFA procedure time in each patient.
Time Frame
1 day
Title
Complication
Description
all complication rate and grades (according to Clavien system from I to III) related with RFA procedure
Time Frame
12 months
Title
Volume of ablative zone
Description
Volume of ablative zone on post-RFA CT or MRI in a mm3.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
US/CT or MR fusion success rate
Description
RFA is performed under real time US guidance and US is fused with pre-RFA CT or MRI before ablation of the index tumor. US/CT or US/MR fusion quality is assessed by an operator.
Time Frame
1 day
Title
Immediate assess of technique success rate
Description
After performing RFA, patients were transferred CT unit to confirm immediate technique success. It is performed in both a) visual inspection using pre-and post-RFA images side-by-side comparison and b) software assisted inspection which register pre-and post-RFA scans. The results would be used to perform additional treatment (2nd look RFA).
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all conditions have to be fulfilled.
Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
signed informed consent
treatment naive index tumor (no history of local treatment for an index tumor)
Exclusion Criteria:
more than three tumors in a patients
tumor size larger than 5cm
tumor attaches to central portal vein or hepatic vein
Child-Pugh classification C
uncorrected coagulopathy
presence of extrahepatic metastases
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiofrequency Ablation Using Cooled-Wet Electrode
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