- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471272
RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes
Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual RF Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeong Min Lee, MD, PhD
- Phone Number: +82-2072-3107
- Email: jmlshy2000@gmail.com
Study Locations
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Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
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Contact:
- SAE JIN PARK, MD
- Phone Number: 82220723107
- Email: psjko05@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RFA using gradual RF energy delivery mode
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ideal technical success rate
Time Frame: Time: immediately
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Secure a safety margin of 5 mm or more around the tumor on CT obtained immediately after the procedure
|
Time: immediately
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ablation volume
Time Frame: Time: immediately
|
Volume of ablation lesions per unit time measured on CT obtained immediately after the procedure
|
Time: immediately
|
Local recurrence rate
Time Frame: Time: 12months
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Local recurrence rate of 12 months after the procedure
|
Time: 12months
|
Overall survival rate
Time Frame: Time: 3years
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Survival rate after the procedure
|
Time: 3years
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Disease free survival
Time Frame: Time: 3years
|
disease-free survival rate after the procedure
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Time: 3years
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Complication rate
Time Frame: Time: immediately
|
The incidence of complications associated with the procedure
|
Time: immediately
|
Technical time
Time Frame: Time: immediately
|
The actual procedure time
|
Time: immediately
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-1909-086-1064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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