HCC, Metastasis
Conditions
Keywords
RFA
Brief summary
To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.
Detailed description
To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.
Interventions
DEVICEcooled-wet electrode
RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.
RFA is performed using separable clustered electrode in switching monopolar mode.
Sponsors
RF medical
Medical Research Collaborating Center
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
all conditions have to be fulfilled. * Diagnosed with HCC (1\ 5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA * liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging * signed informed consent * treatment naive index tumor (no history of local treatment for an index tumor)
Exclusion criteria
* more than three tumors in a patients * tumor size larger than 5cm * tumor attaches to central portal vein or hepatic vein * Child-Pugh classification C * uncorrected coagulopathy * presence of extrahepatic metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LTP | 24 months | cumulating local tumor progression rate over 2- year after RFA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IDR rate | 24 months | cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA |
| Complication | 12 months | all complication rate and grades (according to Clavien system from I to III) related with RFA procedure |
| Volume of ablative zone | 7 days | Volume of ablative zone on post-RFA CT or MRI in a mm3. |
| Maximal diameter of ablative zone | 7 day | Maximal diameter of ablative zone on post-RFA CT or MRI in a mm. |
| Technical success rate | 1 months | technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI) |
| ablation time | 1 day | RFA procedure time in each patient. |
| EM rate | 24 months | cumulating extrahepatic metastasis (EM) rate over 2- year after RFA |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immediate assess of technique success rate | 2 days | After performing RFA, patients were transferred CT unit to confirm immediate technique success. It is performed in both a) visual inspection using pre-and post-RFA images side-by-side comparison and b) software assisted inspection which register pre-and post-RFA scans. The results would be used to perform additional treatment (2nd look RFA). |
| US/CT or MR fusion success rate | 1 day | RFA is performed under real time US guidance and US is fused with pre-RFA CT or MRI before ablation of the index tumor. US/CT or US/MR fusion quality is assessed by an operator. |
Countries
South Korea
Outcome results
None listed