Carcinoma, HepatocellularNCT02806076
RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode
A study testing No-touch RFA arm and Conventional tumor puncture RFA arm in people with Carcinoma, Hepatocellular, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- No-touch RFA arm and Conventional tumor puncture RFA arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2016to 30 Mar 2024
- 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
- patient with 1-2.5cm sized HCC
- 1 or 2 HCC lesions
Who cannot join
- maximum tumor diameter greater than 2.5cm
- Child-Pugh class B or C
- more than 3 HCC lesions
- invisible tumor even after US/CT or US/MR fusion
- presence of vascular tumor thrombosis or extrahepatic metastasis
- severe coagulopathy (PLT < 50K, PT < 50% of normal range)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jeong Min Lee, MD, PhD
About this study
Official title: Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study
The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- No-touch RFA arm, Conventional tumor puncture RFA arm
- Keywords
- HCC, 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.
No-touch RFA armProcedure or surgery
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
Conventional tumor puncture RFA armProcedure or surgery
Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.
| Study group | Role | What they receive |
|---|---|---|
| No-touch RFA arm | Experimental | No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode. Receives: Procedure: No-touch RFA arm |
| Conventional tumor puncture RFA arm | Active comparator | Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode. Receives: Procedure: Conventional tumor puncture RFA arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month local tumor progression (LTP) rate
Measured: 12 months after RFA
Secondary outcomes (3)
2. tumor seeding rate
Measured: 12 months after RFA
Complication rate related with RFA
RFA-related complication rate such as death, abscess, bleeding..etc.
Measured: 1 month after RFA
Technical success rate
presence or absence of residual lesion on follow-up imaging
Measured: 1 month after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806076
- Sponsor's protocol ID
- SNUH-2016-2243
- Status last verified
- Mar 2021
- First submitted
- 3 Jun 2016
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study
- ClinicalTrials.gov ID
- NCT02806076
- Acronym / sponsor ID
- SNUH-2016-2243
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- HCC, RFA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- 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 purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-touch RFA arm | Experimental | Procedure: No-touch RFA armNo-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode. |
| Conventional tumor puncture RFA arm | Active comparator | Procedure: Conventional tumor puncture RFA armConventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode. |
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
- patient with 1-2.5cm sized HCC
- 1 or 2 HCC lesions
Key exclusion criteria (6 listed)
- maximum tumor diameter greater than 2.5cm
- Child-Pugh class B or C
- more than 3 HCC lesions
- invisible tumor even after US/CT or US/MR fusion
- presence of vascular tumor thrombosis or extrahepatic 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 |
|---|---|---|
| No-touch RFA armNo-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode. | Procedure or surgery | No-touch RFA arm |
| Conventional tumor puncture RFA armConventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode. | Procedure or surgery | Conventional tumor puncture RFA arm |
Primary outcome
12 month local tumor progression (LTP) rate
Time frame: 12 months after RFA
3 secondary outcomes
2. tumor seeding rate
Time frame: 12 months after RFA
Complication rate related with RFA
Time frame: 1 month after RFA
Technical success rate
Time frame: 1 month after RFA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- 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, MD 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 No-touch RFA arm and Conventional tumor puncture RFA arm in people with 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 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: status not confirmed, as of the sponsor's last update on 19 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 Hyun Hee Lee, RN (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?
12 month local tumor progression (LTP) rate (time frame: 12 months after RFA). 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 19 Mar 2021.