Hepatocellular CarcinomaNCT03375281
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique
A study testing RFA in people with Hepatocellular Carcinoma and Radiofrequency Ablation, run by Seoul National University Hospital at 5 sites in South Korea.
Trial summary
The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC using no touch technique with separable clustered electrode (Octopus) in a prospective multicenter manner Participating center: Seoul national university hospital, Asan medical center, Samsung medical center, Kunkuk university… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma, Radiofrequency Ablation
- What is being tested?
- RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 20 Nov 2017to 21 Aug 2020
- 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 liver function
- 1 - 2.5 cm sized Single nodular HCC
- without history of previous HCC treatment or with evidence of no recurrence at least 2 years after previous HCC treatment
Who cannot join
- more than 2 HCC
- tumor size larger than 2.5 cm
- Child-Pugh class B or C liver function
- invisible tumor even after real-time fusion US guidance
- accompanied by vascular invasion or distant metastasis
- presence of coagulopathy defined as platelet count < 50,000/mm3 and/or PT-INR > 50%
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Asan medical Center
Seoul, 05505
Samsung medical center
Seoul, 06351
KonKuk university hospital
Seoul
Saint Mary Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique: A Prospective Single Arm Study
The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC using no touch technique with separable clustered electrode (Octopus) in a prospective multicenter manner Participating center: Seoul national university hospital, Asan medical center, Samsung medical center, Kunkuk university hospital, St. mary's Seoul hospital
- Conditions
- Hepatocellular Carcinoma, Radiofrequency Ablation
- Being tested
- RFA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFAProcedure or surgery
thermal ablation using radiofrequency for HCC
| Study group | Role | What they receive |
|---|---|---|
| No touch group | Experimental | RFA for small HCC would be done by using no touch technique Receives: Procedure: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year local tumor progression
cumulative incidence of local tumor progression after RFA
Measured: 1 year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start20 Nov 2017
- Primary completion28 Jan 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 140 participants (actual)
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
- NCT03375281
- Sponsor's protocol ID
- SNUH-2017-0870
- Status last verified
- Mar 2021
- First submitted
- 12 Dec 2017
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee DH, Lee MW, Kim PN, Lee YJ, Park HS, Lee JM. Outcome of No-Touch Radiofrequency Ablation for Small Hepatocellular Carcinoma: A Multicenter Clinical Trial. Radiology. 2021 Oct;301(1):229-236. doi: 10.1148/radiol.2021210309. Epub 2021 Jul 27.
PubMed 34313474
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique: A Prospective Single Arm Study
- ClinicalTrials.gov ID
- NCT03375281
- Acronym / sponsor ID
- SNUH-2017-0870
- Conditions
- Hepatocellular Carcinoma, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Starmed
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 18 Dec 2017 (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.
The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC using no touch technique with separable clustered electrode (Octopus) in a prospective multicenter manner Participating center: Seoul national university hospital, Asan medical center, Samsung medical center, Kunkuk university hospital, St. mary's Seoul hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No touch group | Experimental | Procedure: RFARFA for small HCC would be done by using no touch technique |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Child-Pugh class A liver function
- 1 - 2.5 cm sized Single nodular HCC
- without history of previous HCC treatment or with evidence of no recurrence at least 2 years after previous HCC treatment
Key exclusion criteria (6 listed)
- more than 2 HCC
- tumor size larger than 2.5 cm
- Child-Pugh class B or C liver function
- invisible tumor even after real-time fusion US guidance
- accompanied by vascular invasion or distant metastasis
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 |
|---|---|---|
| RFAthermal ablation using radiofrequency for HCC | Procedure or surgery | No touch group |
Primary outcome
1 year local tumor progression
Time frame: 1 year after procedure
cumulative incidence of local tumor progression after RFA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 34313474Lee DH, Lee MW, Kim PN, Lee YJ, Park HS, Lee JM. Outcome of No-Touch Radiofrequency Ablation for Small Hepatocellular Carcinoma: A Multicenter Clinical Trial. Radiology. 2021 Oct;301(1):229-236. doi: 10.1148/radiol.2021210309. Epub 2021 Jul 27.
- 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA in people with Hepatocellular Carcinoma and Radiofrequency Ablation, run by Seoul National University Hospital at 5 sites 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 3 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: finished, as of the sponsor's last update on 23 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 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year local tumor progression (time frame: 1 year after procedure). 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 NCT03375281, which also lists 1 linked publication.
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 23 Mar 2021.