No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma Using Triple Cooled-Wet Electrodes

Study Overview
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Brief Summary
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To evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes

Official Title
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No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes

Conditions
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Recurrent Hepatocellular Cancer, Chronic Liver Disease and Cirrhosis

Intervention / Treatment
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* Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child-Pugh Class A or B chronic hepatitis B or chronic hepatitis C or liver cirrhosis presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018 single lesion less than or equal to 5 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment Exclusion Criteria: number of recurrent HCCs, equal or more than 3 largest recurrent HCC size over 3 cm presence of vascular invasion by HCC platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50% presence of extrahepatic metastasis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with recurrent hepatocellular carcinoma after locoregional treatment<br>Patients with chronic liver disease have recurrent hepatocellular carcinoma which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). | Procedure: Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes<br>* Radiofrequency ablation will be performed by using triple cooled-wet electrodes. Two or three electrodes will be places around the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF, bipolar mode and switching monopolar mode) will be applied to two of three electrodes at the same time for about 6 to 30 minutes depending on the tumor size. The temperature will be maintained at 90-100 °C.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor progression rate | Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level | 12 months after radiofrequency ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level | 12 moths after radiofrequency ablation | 
| Technical success rate | Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 3 mm on 1 month follow-up CT. | 1 month after radiofrequency ablation | 
| Overall survival | Evaluate overall survival by available clinical information and follow-up | 12 moths after radiofrequency ablation | 
| Complication rate | Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging. | 1, 3, 6, 9, 12 months after radiofrequency ablation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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No-touch radiofrequency ablation, Combined energy delivery mode, Triple cooled-wet electrodes