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Radiofrequency AblationNCT04331184

RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes

A study testing RFA using combined bipolar and monopolar energy deliver 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 20 to 85 years
What is being tested?
RFA using combined bipolar and monopolar energy deliver
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteSouth Korea
Study dates
28 Jan 2020to 30 Dec 2022
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 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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 Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study

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.

Read the 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%).

Being tested
RFA using combined bipolar and monopolar energy deliver
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 combined bipolar and monopolar energy deliverProcedure or surgery

    RFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization.

Study groups in NCT04331184
Study groupRoleWhat they receive
RFA using combined bipolar and monopolar energy deliveryExperimentalControl group: The historic cohort is used to compare the results of the conventional alternating unipolar radiofrequency energy transfer mode with RFA.
Receives: Procedure: RFA using combined bipolar and monopolar energy deliver

What is being measured

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

  1. Local tumor progression

    Measured: 12 months

Secondary outcomes (5)
  1. Overall survival rate

    Survival data

    Measured: 12 months

  2. Recurrence free survival

    Survival data

    Measured: 12 months

  3. Procedure time

    Procedure related outcome

    Measured: immediately

  4. complication rate

    Procedure related outcome

    Measured: immediately

  5. technical success rate

    Procedure related outcome

    Measured: immediately

Timeline

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

  1. First posted2 Apr 2020
  2. Study start28 Jan 2020
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Dec 2022 (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
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04331184
Sponsor's protocol ID
H-1907-157-1050
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 combined bipolar and monopolar energy deliver 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local tumor progression (time frame: 12 months). 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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