Radiofrequency AblationNCT04803890
"No-Touch" Radiofrequency Ablation for Small Hepatocellular Carcinoma (≤ 3cm): A Prospective Multicenter Study
A study testing "No-Touch" Radiofrequency Ablation in people with Radiofrequency Ablation and Microwave Ablation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a prospective multicenter study of the duration of treatment, the success rate, the frequency of complications, and the local recurrence rate of 12 months when Radio-frequency ablation therapy is performed for the treatment of HCC using the 'No touch' technique as a combined high-frequency transmission… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Radiofrequency Ablation, Microwave Ablation
- What is being tested?
- "No-Touch" Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 10 Mar 2021
- 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 or B7
- Among patients with cirrhosis, patients with hepatocellular carcinoma having a size of 1 cm-3 cm suspected of MDCT or MRI performed within 60 days are considered for radio-frequency ablation
- Patients who do not have a history of treatment for previous hepatocellular carcinoma, or who have a history of treatment for previous hepatocellular carcinoma, if recurrence has not been confirmed for at least 2 years after treatment
Who cannot join
- the number of liver tumors is 3 or more
- the maximum size of the tumor exceeds 3 cm
- diffuse infiltrative type
- the tumor adheres to the portal vein or hepatic vein or biliary tract of 5 mm or more
- patients with previous medical history of hepatocellular cancer who have recurrent hepatocellular cancer within 2 years
- the tumor is not visible even under CEUS-fusion image guidance
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- Child-Pugh class B8 or C
- in case of invasion of liver vessels due to malignant hepatocellular carcinoma
- severe coagulopathy
- multiple distant metastasis
- the situation where the probability of obtaining appropriate data suitable for the research purpose is very low
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "No-Touch" Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode for Small Hepatocellular Carcinoma (≤ 3cm): A Prospective Multicenter Study
This study is a prospective multicenter study of the duration of treatment, the success rate, the frequency of complications, and the local recurrence rate of 12 months when Radio-frequency ablation therapy is performed for the treatment of HCC using the 'No touch' technique as a combined high-frequency transmission mode with Octopus electrodes. It aims to evaluate through. In addition, the results obtained from this prospective study were as follows: 1) Patients who underwent Radio-frequency ablation therapy by puncturing an existing tumor, and 2) Patients who underwent microwave ablation during the study period. The secondary goal is to evaluate which method is more effective in reducing the treatment time and recurrence rate compared to.
Read the detailed description
- 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 RFA. That is, after confirming the location of the tumor in the Multiphasic CT or MRI and evaluating the volume of the tumor and the relationship with adjacent blood vessels before RFA procedure, planning the insertion path and the number of ablation of the electrode for RFA, the recently used US- The CT-MR fusion tool is used to fuse the pre-treatment image and the ultrasound image to evaluate whether the tumor location on the ultrasound image matches the tumor found on the pre-treatment image. The location will be evaluated in real time. The end of the procedure is when an echo bubble of 5 mm to 10 mm or more is generated around the treated tumor, and it is confirmed that the enhancement of HCC disappears completely after RFA in immediate post procedure CT. In addition, if the boundary of the tumor is not well drawn on ultrasound, CEUS will be additionally used to confirm the location of the tumor. At this time, the ultrasonic fusion device to be used will be one of Phillips, GE, Samsung or Siemens' navigation systems available herein. The fused image guides the location of the electrodes to be installed in the tumor, the number of electrodes, and a safe access route.
- RFA procedure As a device for RFA, a multi-viva generator and a separable clustered electrode (product name: Octopus electrode, Starmed Ltd), which are used herein, will be used. The procedure is to place the octopus high-frequency electrode in the periphery of the tumor (5 ± 2mm) using no touch technique under fusion ultrasound guidance, and then simultaneously apply high frequency to two electrodes up to 200W using the combined monopolar-bipolar mode with keeping the temperature at 90-100 degrees Celsius for about 5 to 30 minutes until the tumor and 5-10 mm echo band form around the tumor. During the RFA procedure, the US-CT-MR fusion tool (Navigator- GE \& Siemens, Samsung) is used to fuse the pre-treatment image and the ultrasound image to match the echo bubble distribution and tumor location. It will be evaluated in real time. If the boundary of the tumor is unclear, it is difficult to grasp the boundary of the tumor 360 degrees as a whole, or if there is little normal tissue to install electrodes around the tumor, it is difficult to apply the No-touch technique. Therefore, in this study, the application rate of the No-touch technique will be evaluated among all recruited patients, and when evaluating the presence or absence of recurrence after the procedure, it is analyzed (intention to treat analysis) including puncture of the tumor, and treated with actual No-touch. It will be analyzed further.
- Follow-up
- CT (MRI if CT is contraindicated) will be performed immediately after RFA therapy as previously performed as a clinical routine, and it will be evaluated whether complete necrosis of the treated tumor has been achieved. If residual masses are identified or insufficient safety margins are not secured, additional procedures are performed and evaluated.
- Alternatively, AFP or CEA, CBC, LFT and CT or MRI are performed 1 to 3 months after RFA procedure.
- The follow up method is the same as the existing method, and blood tests and CT or MRI tests are performed every 3 to 4 months for 3 to 4 times during 12 months. This is due to the fact that most local recurrence occurs within 12 months, and the local recurrence rate will be evaluated based on this.
- The final point of time for this study is based on the follow-up findings obtained at 12 ± 1 month after the procedure (short-term relapse rate evaluation).
- However, after that, the patient will continue to perform CT or MR follow-up every 3 to 6 months until 2 years according to the routine follow-up protocol of the patient who has undergone existing RFA therapy.
- Control group Of the patients who underwent RFA therapy for the treatment of HCC for a period of 2 years from 2018 to 2020, the patient group had been treated with conventional RFA and microwave ablation were enrolled. After performing the propensity score matching analysis using variables of age, gender, tumor size, tumor location, and liver function values, the same number of controls are selected and set.
- Conditions
- Radiofrequency Ablation, Microwave Ablation
- Being tested
- "No-Touch" Radiofrequency Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"No-Touch" Radiofrequency AblationProcedure or surgery
"No-Touch" Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode
| Study group | Role | What they receive |
|---|---|---|
| No touch radiofrequency ablation | Experimental | A total of 150 patients who have decided to participate in the study will be included, and prospective study will be performed to these patients for radio-frequency ablation using octopus electrodes, combined high-frequency transmission mode, and the 'No touch' technique. Receives: Procedure: "No-Touch" Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor progression (LTP) rate
No. of participants with LTP/ No. of participants receiving RFA
Measured: 12 months after RFA
Secondary outcomes (2)
Intrahepatic distant recurrence (IDR) rate
No. of participants with IDR/ No. of participants receiving RFA
Measured: 12 months after RFA
Complication rate
No. of procedure-related complication/No. of participants receiving RFA
Measured: 12 months after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Apr 2019
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Why it stopped: Early termination d/t overlap with a new, extended protocol study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency AblationStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Chosun University Hospital
- 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
- NCT04803890
- Sponsor's protocol ID
- H-2003-068-1108
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "No-Touch" Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode for Small Hepatocellular Carcinoma (≤ 3cm): A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04803890
- Acronym / sponsor ID
- H-2003-068-1108
- Conditions
- Radiofrequency Ablation, Microwave Ablation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination d/t overlap with a new, extended protocol study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Chosun University Hospital
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 18 Mar 2021 (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.
This study is a prospective multicenter study of the duration of treatment, the success rate, the frequency of complications, and the local recurrence rate of 12 months when Radio-frequency ablation therapy is performed for the treatment of HCC using the 'No touch' technique as a combined high-frequency transmission mode with Octopus electrodes. It aims to evaluate through. In addition, the results obtained from this prospective study were as follows: 1) Patients who underwent Radio-frequency ablation therapy by puncturing an existing tumor, and 2) Patients who underwent microwave ablation during the study period. The secondary goal is to evaluate which method is more effective in reducing the treatment time and recurrence rate compared to.
Detailed description
- 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 RFA. That is, after confirming the location of the tumor in the Multiphasic CT or MRI and evaluating the volume of the tumor and the relationship with adjacent blood vessels before RFA procedure, planning the insertion path and the number of ablation of the electrode for RFA, the recently used US- The CT-MR fusion tool is used to fuse the pre-treatment image and the ultrasound image to evaluate whether the tumor location on the ultrasound image matches the tumor found on the pre-treatment image. The location will be evaluated in real time. The end of the procedure is when an echo bubble of 5 mm to 10 mm or more is generated around the treated tumor, and it is confirmed that the enhancement of HCC disappears completely after RFA in immediate post procedure CT. In addition, if the boundary of the tumor is not well drawn on ultrasound, CEUS will be additionally used to confirm the location of the tumor. At this time, the ultrasonic fusion device to be used will be one of Phillips, GE, Samsung or Siemens' navigation systems available herein. The fused image guides the location of the electrodes to be installed in the tumor, the number of electrodes, and a safe access route.
- RFA procedure As a device for RFA, a multi-viva generator and a separable clustered electrode (product name: Octopus electrode, Starmed Ltd), which are used herein, will be used. The procedure is to place the octopus high-frequency electrode in the periphery of the tumor (5 ± 2mm) using no touch technique under fusion ultrasound guidance, and then simultaneously apply high frequency to two electrodes up to 200W using the combined monopolar-bipolar mode with keeping the temperature at 90-100 degrees Celsius for about 5 to 30 minutes until the tumor and 5-10 mm echo band form around the tumor. During the RFA procedure, the US-CT-MR fusion tool (Navigator- GE \& Siemens, Samsung) is used to fuse the pre-treatment image and the ultrasound image to match the echo bubble distribution and tumor location. It will be evaluated in real time. If the boundary of the tumor is unclear, it is difficult to grasp the boundary of the tumor 360 degrees as a whole, or if there is little normal tissue to install electrodes around the tumor, it is difficult to apply the No-touch technique. Therefore, in this study, the application rate of the No-touch technique will be evaluated among all recruited patients, and when evaluating the presence or absence of recurrence after the procedure, it is analyzed (intention to treat analysis) including puncture of the tumor, and treated with actual No-touch. It will be analyzed further.
- Follow-up
- CT (MRI if CT is contraindicated) will be performed immediately after RFA therapy as previously performed as a clinical routine, and it will be evaluated whether complete necrosis of the treated tumor has been achieved. If residual masses are identified or insufficient safety margins are not secured, additional procedures are performed and evaluated.
- Alternatively, AFP or CEA, CBC, LFT and CT or MRI are performed 1 to 3 months after RFA procedure.
- The follow up method is the same as the existing method, and blood tests and CT or MRI tests are performed every 3 to 4 months for 3 to 4 times during 12 months. This is due to the fact that most local recurrence occurs within 12 months, and the local recurrence rate will be evaluated based on this.
- The final point of time for this study is based on the follow-up findings obtained at 12 ± 1 month after the procedure (short-term relapse rate evaluation).
- However, after that, the patient will continue to perform CT or MR follow-up every 3 to 6 months until 2 years according to the routine follow-up protocol of the patient who has undergone existing RFA therapy.
- Control group Of the patients who underwent RFA therapy for the treatment of HCC for a period of 2 years from 2018 to 2020, the patient group had been treated with conventional RFA and microwave ablation were enrolled. After performing the propensity score matching analysis using variables of age, gender, tumor size, tumor location, and liver function values, the same number of controls are selected and set.
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 radiofrequency ablation | Experimental | Procedure: "No-Touch" Radiofrequency AblationA total of 150 patients who have decided to participate in the study will be included, and prospective study will be performed to these patients for radio-frequency ablation using octopus electrodes, combined high-frequency transmission mode, and the '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 (5 listed)
- Agree to the protocol's requirements and submit a consent form
- 20 years old-85 years old
- Child-Pugh Class A or B7
- Among patients with cirrhosis, patients with hepatocellular carcinoma having a size of 1 cm-3 cm suspected of MDCT or MRI performed within 60 days are considered for radio-frequency ablation
- Patients who do not have a history of treatment for previous hepatocellular carcinoma, or who have a history of treatment for previous hepatocellular carcinoma, if recurrence has not been confirmed for at least 2 years after treatment
Key exclusion criteria (11 listed)
- the number of liver tumors is 3 or more
- the maximum size of the tumor exceeds 3 cm
- diffuse infiltrative type
- the tumor adheres to the portal vein or hepatic vein or biliary tract of 5 mm or more
- patients with previous medical history of hepatocellular cancer who have recurrent hepatocellular cancer within 2 years
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" Radiofrequency Ablation"No-Touch" Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode | Procedure or surgery | No touch radiofrequency ablation |
Primary outcome
Local tumor progression (LTP) rate
Time frame: 12 months after RFA
No. of participants with LTP/ No. of participants receiving RFA
2 secondary outcomes
Intrahepatic distant recurrence (IDR) rate
Time frame: 12 months after RFA
Complication rate
Time frame: 12 months after RFA
Results and safety
The study was stopped early (reason given: Early termination d/t overlap with a new, extended protocol study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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" Radiofrequency Ablation in people with Radiofrequency Ablation and Microwave Ablation, 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 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?
The study was stopped early (reason given: Early termination d/t overlap with a new, extended protocol study.). Results are not available in the source record.
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?
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 18 Mar 2021.