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Radiofrequency AblationNCT04471272

RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes

A study testing RFA using gradual RF energy delivery mode with Octopus electrodes in people with Radiofrequency Ablation and Carcinoma, Hepatocellular, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 85 years
What is being tested?
RFA using gradual RF energy delivery mode with Octopus electrodes
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSouth Korea
Study dates
6 Jan 2020to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jeong Min Lee, MD, PhD contact

+82-2072-3107

jmlshy2000@gmail.com

South Korea1 site, 1 recruiting
  • Seoul National University Hospital

    Seoul

    SAE JIN PARK, MD, 82220723107, psjko05@gmail.com

    Jeong Min Lee, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual RF Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study

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.

Read the detailed description
  1. 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.
  2. 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.

Being tested
RFA using gradual RF energy delivery mode with Octopus electrodes
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RFA using gradual RF energy delivery mode with Octopus electrodesProcedure or surgery

    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.

Study groups in NCT04471272
Study groupRoleWhat they receive
RFA using gradual RF energy delivery modeExperimentalRFA 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.
Receives: Procedure: RFA using gradual RF energy delivery mode with Octopus electrodes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ideal technical success rate

    Secure a safety margin of 5 mm or more around the tumor on CT obtained immediately after the procedure

    Measured: Time: immediately

Secondary outcomes (6)
  1. Ablation volume

    Volume of ablation lesions per unit time measured on CT obtained immediately after the procedure

    Measured: Time: immediately

  2. Local recurrence rate

    Local recurrence rate of 12 months after the procedure

    Measured: Time: 12months

  3. Overall survival rate

    Survival rate after the procedure

    Measured: Time: 3years

  4. Disease free survival

    disease-free survival rate after the procedure

    Measured: Time: 3years

  5. Complication rate

    The incidence of complications associated with the procedure

    Measured: Time: immediately

  6. Technical time

    The actual procedure time

    Measured: Time: immediately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2020
  2. Study start6 Jan 2020
  3. Primary completion30 Aug 2022 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04471272
Sponsor's protocol ID
H-1909-086-1064
Status last verified
Mar 2021
First submitted
31 Mar 2020
Last updated
17 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing RFA using gradual RF energy delivery mode with Octopus electrodes in people with Radiofrequency Ablation and Carcinoma, Hepatocellular, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jeong Min Lee, MD, PhD (+82-2072-3107, jmlshy2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ideal technical success rate (time frame: Time: immediately). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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