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| Name | Class |
|---|---|
| RF medical | UNKNOWN |
| Medical Research Collaborating Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA with cooled-wet electrode | Active Comparator | RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance. |
|
| RFA with separable clustered electrode | Active Comparator | RFA using separable clustered electrode in switching monopolar mode under the fused US guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cooled-wet electrode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| LTP | cumulating local tumor progression rate over 2- year after RFA | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI) | 1 months |
| IDR rate | cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA |
| Measure | Description | Time Frame |
|---|---|---|
| US/CT or MR fusion success rate | 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. | 1 day |
| Immediate assess of technique success rate |
Inclusion Criteria: all conditions have to be fulfilled.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| separable clustered electrode | Device | RFA is performed using separable clustered electrode in switching monopolar mode. |
|
|
| 24 months |
| EM rate | cumulating extrahepatic metastasis (EM) rate over 2- year after RFA | 24 months |
| Maximal diameter of ablative zone | Maximal diameter of ablative zone on post-RFA CT or MRI in a mm. | 7 day |
| ablation time | RFA procedure time in each patient. | 1 day |
| Complication | all complication rate and grades (according to Clavien system from I to III) related with RFA procedure | 12 months |
| Volume of ablative zone | Volume of ablative zone on post-RFA CT or MRI in a mm3. | 7 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). |
| 2 days |