RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes
Primary Purpose
Radiofrequency Ablation, Carcinoma, Hepatocellular
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RFA using gradual RF energy delivery mode with Octopus electrodes
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
- among patients with chronic hepatitis or cirrhosis, MDCT or MRI hepatocellular carcinoma of less than 4 cm in size was suspected, and was referred to the radiology department considering clinical RFA therapy as a clinical judgment.
Exclusion Criteria:
- when the number of malignant HCC is 3 or more
- if the tumor has a maximum size of more than 4 cm
- diffuse infiltrative HCC
- Child-Pugh class B or C
- If there is an invasion of liver vessels due to malignant HCC
- 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 gradual RF energy delivery mode
Arm 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.
Outcomes
Primary Outcome Measures
Ideal technical success rate
Secure a safety margin of 5 mm or more around the tumor on CT obtained immediately after the procedure
Secondary Outcome Measures
Ablation volume
Volume of ablation lesions per unit time measured on CT obtained immediately after the procedure
Local recurrence rate
Local recurrence rate of 12 months after the procedure
Overall survival rate
Survival rate after the procedure
Disease free survival
disease-free survival rate after the procedure
Complication rate
The incidence of complications associated with the procedure
Technical time
The actual procedure time
Full Information
NCT ID
NCT04471272
First Posted
March 31, 2020
Last Updated
March 16, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04471272
Brief Title
RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes
Official Title
Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual RF Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (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
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.
Detailed Description
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.
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.
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
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RFA using gradual RF energy delivery mode
Arm Type
Experimental
Arm 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(s)
RFA using gradual RF energy delivery mode with Octopus electrodes
Intervention 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.
Primary Outcome Measure Information:
Title
Ideal technical success rate
Description
Secure a safety margin of 5 mm or more around the tumor on CT obtained immediately after the procedure
Time Frame
Time: immediately
Secondary Outcome Measure Information:
Title
Ablation volume
Description
Volume of ablation lesions per unit time measured on CT obtained immediately after the procedure
Time Frame
Time: immediately
Title
Local recurrence rate
Description
Local recurrence rate of 12 months after the procedure
Time Frame
Time: 12months
Title
Overall survival rate
Description
Survival rate after the procedure
Time Frame
Time: 3years
Title
Disease free survival
Description
disease-free survival rate after the procedure
Time Frame
Time: 3years
Title
Complication rate
Description
The incidence of complications associated with the procedure
Time Frame
Time: immediately
Title
Technical time
Description
The actual procedure time
Time Frame
Time: 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
among patients with chronic hepatitis or cirrhosis, MDCT or MRI hepatocellular carcinoma of less than 4 cm in size was suspected, and was referred to the radiology department considering clinical RFA therapy as a clinical judgment.
Exclusion Criteria:
when the number of malignant HCC is 3 or more
if the tumor has a maximum size of more than 4 cm
diffuse infiltrative HCC
Child-Pugh class B or C
If there is an invasion of liver vessels due to malignant HCC
severe coagulopathy
multiple distant metastasis
situations where it is very unlikely to obtain appropriate data for research purposes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Min Lee, MD, PhD
Phone
+82-2072-3107
Email
jmlshy2000@gmail.com
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
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RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes
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