Hepatocellular CarcinomaNCT05397860
Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment
A study testing Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Liver Disease
- What is being tested?
- Radiofrequency ablation using gradual radiofrequency energy delivery 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 Aug 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
- Child-Pugh Class A or B
- chronic hepatitis B or liver cirrhosis
- contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date
- clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm
Who cannot join
- number of HCC, equal or more than 3
- largest tumor size over 4 cm
- Child-Pugh class C
- presence of vascular invasion by HCC
- platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
- presence of extrahepatic metastasis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyun Hee Lee, RN, 82-2-2072-4177, redlion55@naver.com
Jae Hyun Kim, MD, 82-2-2072-2519, yyssaa21@gmail.com
About this study
Official title: Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study
To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.
- Being tested
- Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes
- Keywords
- Radiofrequency ablation, Gradual radiofrequency energy increment, Cone-unit ablation
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodesProcedure or surgery
Radiofrequency ablation (RFA) will be performed by using multi-VIVA generator and Octopus electrodes. Three electrodes will be placed on the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF) will be applied to two of three electrodes at the same time for about 6 to 30 minutes depending on the tumor size. The temperature will be maintained at 90-100 °C. The RF energy will starts at 60 watts and increase by 10 watts every 30 seconds for the first 3 minutes, and then increases gradually by 10 watts per minute after reaching 100 watts.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm ) | Experimental | Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). Receives: Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor progression rate
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level
Measured: 12 months after radiofrequency ablation (RFA)
Secondary outcomes (1)
Success rate of cone-unit ablation
The cone-unit ablation is defined as complete ablation of tumor with safety margin and occlusion of the 4th or 5th branches of portal vein.
Measured: Immediately after radiofrequency ablation (RFA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start6 Jan 2020
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Starmed
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397860
- Sponsor's protocol ID
- 1909-086-1064
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang S, Kim JH, Yu SJ, Lee JM. Incremental high power radiofrequency ablation with multi-electrodes for small hepatocellular carcinoma: a prospective study. BMC Gastroenterol. 2024 Aug 21;24(1):280. doi: 10.1186/s12876-024-03358-w.
PubMed 39169297Kim JH, Kim HS, Yoon JH, Joo I, Yoon JH, Kim YJ, Yu SJ, Lee JM. Anatomical ablation for small hepatocellular carcinomas using multiple applicators: a preliminary study. Cancer Imaging. 2023 Aug 21;23(1):78. doi: 10.1186/s40644-023-00597-0.
PubMed 37605251
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05397860
- Acronym / sponsor ID
- 1909-086-1064
- Keywords
- Radiofrequency ablation, Gradual radiofrequency energy increment, Cone-unit ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Starmed
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm ) | Experimental | Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodesPatients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Child-Pugh Class A or B
- chronic hepatitis B or liver cirrhosis
- contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date
- clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm
Key exclusion criteria (6 listed)
- number of HCC, equal or more than 3
- largest tumor size over 4 cm
- Child-Pugh class C
- presence of vascular invasion by HCC
- platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodesRadiofrequency ablation (RFA) will be performed by using multi-VIVA generator and Octopus electrodes. Three electrodes will be placed on the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF) will be applied to two of three electrodes at the same time for about 6 to 30 minutes depending on the tumor size. The temperature will be maintained at 90-100 °C. The RF energy will starts at 60 watts and increase by 10 watts every 30 seconds for the first 3 minutes, and then increases gradually by 10 watts per minute after reaching 100 watts. | Procedure or surgery | Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm ) |
Primary outcome
Local tumor progression rate
Time frame: 12 months after radiofrequency ablation (RFA)
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level
1 secondary outcome
Success rate of cone-unit ablation
Time frame: Immediately after radiofrequency ablation (RFA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 39169297Hwang S, Kim JH, Yu SJ, Lee JM. Incremental high power radiofrequency ablation with multi-electrodes for small hepatocellular carcinoma: a prospective study. BMC Gastroenterol. 2024 Aug 21;24(1):280. doi: 10.1186/s12876-024-03358-w.
- Derived from this study: PubMed 37605251Kim JH, Kim HS, Yoon JH, Joo I, Yoon JH, Kim YJ, Yu SJ, Lee JM. Anatomical ablation for small hepatocellular carcinomas using multiple applicators: a preliminary study. Cancer Imaging. 2023 Aug 21;23(1):78. doi: 10.1186/s40644-023-00597-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Min Lee, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes in people with Hepatocellular Carcinoma and Liver Cirrhosis, 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 6 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 15 Jun 2022. 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 Hyun Hee Lee (82-2-2072-4177, redlion55@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor progression rate (time frame: 12 months after radiofrequency ablation (RFA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397860, which also lists 2 linked publications.
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 15 Jun 2022.