Radiofrequency Ablation Using Cooled-Wet Electrode

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study

Conditions
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HCC, Metastasis

Intervention / Treatment
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* Device: cooled-wet electrode
* Device: separable clustered electrode


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RFA with cooled-wet electrode<br>RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance. | Device: cooled-wet electrode<br>* 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.<br>|
| Active Comparator: RFA with separable clustered electrode<br>RFA using separable clustered electrode in switching monopolar mode under the fused US guidance | Device: separable clustered electrode<br>* RFA is performed using separable clustered electrode in switching monopolar mode.<br>* Other names: Octopus(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LTP | cumulating local tumor progression rate over 2- year after RFA | 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RFA