RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes
Primary Purpose
Radiofrequency Ablation, Carcinoma, Hepatocellular
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RFA using combined bipolar and monopolar energy deliver
Sponsored by
About this trial
This is an interventional treatment trial for Radiofrequency Ablation
Eligibility Criteria
Inclusion Criteria:
- agree to the protocol's requirements and submit a consent form
- 20 years old-85 years old
- Child-Pugh Class A and B
- Patients with residual HCC after locoregional treatment who meet the following conditions A. Patients with a single nodular HCC within 5 cm or multiple nodular HCC of 3 or less in all cases of focal cancer B. Patients who did not have vascular invasion or extrahepatic metastasis during locoregional intervention
Exclusion Criteria:
- When the number of malignant HCC is 3 or more
- If the tumor has a maximum size of 3 cm or more
- diffuse infiltrative HCC
- Child-Pugh class C
- If there is an invasion of liver vessels due to malignant liver tumors
- severe coagulopathy
- multiple distant metastasis
- situations where it is very unlikely to obtain appropriate data for research purposes
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RFA using combined bipolar and monopolar energy delivery
Arm Description
Control group: The historic cohort is used to compare the results of the conventional alternating unipolar radiofrequency energy transfer mode with RFA.
Outcomes
Primary Outcome Measures
Local tumor progression
Secondary Outcome Measures
Overall survival rate
Survival data
Recurrence free survival
Survival data
Procedure time
Procedure related outcome
complication rate
Procedure related outcome
technical success rate
Procedure related outcome
Full Information
NCT ID
NCT04331184
First Posted
March 31, 2020
Last Updated
March 16, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04331184
Brief Title
RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes
Official Title
Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this study, a dual / Twin Cooled-wet electrode was used to perform RFA therapy on residual tumors after transarterial chemo-embolization and to find out the therapeutic results. The primary endpoint is the 12-month local recurrence rate, and the secondary endpoint is the survival rate, disease-free survival rate, actual procedure time, complications associated with the procedure, and the technical success rate for securing a safety margin of 3 mm or more around the tumor.
Detailed Description
In the treatment of HCC, local interventional procedures such as transarterial chemo-embolization and RFA are one of the most widely used methods. The probability of complete necrosis is known to be about 50-60% and 80%, respectively, and in a few cases, viable tumors remain, requiring additional treatment. Thus, in the treatment of residual tumors after locoregional intervention, RFA therapy is known as a safe and effective treatment, and in practice, it can be said to be a treatment that is often performed for the treatment of residual viable tumors. Until now, single or alternating monopolar mode and bipolar mode or multi-bipolar mode have been used for the transfer of radio frequency energy. Unipolar mode is used most frequnetly. Currently, in the present application, an alternating monopolar mode using three electrodes (Octopus electrode) and a bipolar mode using two electrodes (Twin cooled wet electrod, RF Medical) have been mainly used. RFA therapy for residual tumors after locoregional intervention has theoretically some limitations. First, it is difficult to deliver a sufficient amount of the high-frequency electrode per hour due to the high electrical resistance of the tissue due to tissue necrosis, fibrosis, and distribution of non-homogeneous tissue after local intervention. Second, the high frequency energy is distributed non-uniformly in the tissue. One of the ways to overcome this is to generate a high heat in the center and periphery of the tumor to be treated, a method of uniformly transmitting a large amount of energy such as high frequency or microwave, or a strategy to improve the thermal conductivity and electrical conductivity. In order to do this, saline is delivered to the high-frequency electrode to improve electrical conductivity, and at the same time, high-frequency energy can be applied to the center of the tumor and the periphery of the tumor if high-frequency energy can be transferred between the electrodes or around the two electrodes installed in the tumor. It can be evenly delivered and the efficiency of heat transfer is improved, which will improve the therapeutic effect of high-frequency heat therapy on residual tumors after local intervention.
Recently, Rf Medical in Korea has developed a twin cooled wet (TCW) electrode capable of injecting physiological saline into these high frequency electrodes and has been approved for clinical use under medical insurance. About 30% has been used using a bipolar mode, which has a theoretical advantage to concentrate high-frequency energy between the electrode and the electrode. However, according to the experience in the present application, when the bipolar mode is used, the rate of ablation is very fast and the transmission of high-frequency energy is relatively easy in the center of the tumor, but the transmission of high-frequency energy in the periphery of the tumor is relatively low, resulting in about 30% of tumors. A marginal recurrence or residual tumor was experienced in the margin, and in the last 6 months, bipolar mode and switching monopolar mode were combined to prevent recurrence in the periphery of the tumor, and treatment was performed with the default setting. The result is low recurrence (6 months local recurrence rate of about 15%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiofrequency Ablation, Carcinoma, Hepatocellular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RFA using combined bipolar and monopolar energy delivery
Arm Type
Experimental
Arm Description
Control group: The historic cohort is used to compare the results of the conventional alternating unipolar radiofrequency energy transfer mode with RFA.
Intervention Type
Procedure
Intervention Name(s)
RFA using combined bipolar and monopolar energy deliver
Intervention Description
RFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization.
Primary Outcome Measure Information:
Title
Local tumor progression
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall survival rate
Description
Survival data
Time Frame
12 months
Title
Recurrence free survival
Description
Survival data
Time Frame
12 months
Title
Procedure time
Description
Procedure related outcome
Time Frame
immediately
Title
complication rate
Description
Procedure related outcome
Time Frame
immediately
Title
technical success rate
Description
Procedure related outcome
Time Frame
immediately
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:
agree to the protocol's requirements and submit a consent form
20 years old-85 years old
Child-Pugh Class A and B
Patients with residual HCC after locoregional treatment who meet the following conditions A. Patients with a single nodular HCC within 5 cm or multiple nodular HCC of 3 or less in all cases of focal cancer B. Patients who did not have vascular invasion or extrahepatic metastasis during locoregional intervention
Exclusion Criteria:
When the number of malignant HCC is 3 or more
If the tumor has a maximum size of 3 cm or more
diffuse infiltrative HCC
Child-Pugh class C
If there is an invasion of liver vessels due to malignant liver tumors
severe coagulopathy
multiple distant metastasis
situations where it is very unlikely to obtain appropriate data for research purposes
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SAE JIN PARK, MD
Phone
82220723107
Email
psjko05@gmail.com
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes
We'll reach out to this number within 24 hrs