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Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA DSM | Active Comparator | Eligible patients who undergo RFA using DSM and separable clustered electrodes. |
|
| RFA SSM | No Intervention | Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSM | Device | Monopolar RFA using dual switching mode (DSM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| local tumor progression (LTP) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor) | 1 months | |
| rate of intrahepatic distant recurrence (IDR) after RFA | 12 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complication of RFA | incidence of any possible complication related with RFA | 6 months |
| Maximal diameter of ablative zone | Maximal diameter of ablative zone on post-RFA CT or MRI in a mm. |
Inclusion Criteria:
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 |
A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable. |
|
|
| rate of extrahepatic metastasis (EM) after RFA |
| 12 months |
| 7 day |
| ablation time | ablation time in a patient | 1 day |
| Real time US fusion image feasibility | success or failure of accurate fusion between US and pre-RFA cross sectional images | 1 day after RFA procedure |
| Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration. | Prediction of LTP by classifying patients according to assessing ablative margin in each method on a four point scale (1: residual tumor, 4: ablative margin equal to or larger than 5mm) | 12 months |
| Volume of ablative zone | Volume of ablative zone on post-RFA CT or MRI in a mm3. | 7 days |