Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

Study Overview
=================
Brief Summary
-----------------
To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.

Official Title
-----------------
Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study

Conditions
-----------------
Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Liver Disease

Intervention / Treatment
-----------------
* Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child-Pugh Class A or B chronic hepatitis B or liver cirrhosis contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm Exclusion Criteria: number of HCC, equal or more than 3 largest tumor size over 4 cm Child-Pugh class C 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
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm )<br>Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). | Procedure: Radiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes<br>* Radiofrequency ablation (RFA) will be performed by using multi-VIVA generator and Octopus electrodes. Three electrodes will be placed on the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF) 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. The RF energy will starts at 60 watts and increase by 10 watts every 30 seconds for the first 3 minutes, and then increases gradually by 10 watts per minute after reaching 100 watts.<br>|

What is the study measuring?
-----------------
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 (RFA) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of cone-unit ablation | The cone-unit ablation is defined as complete ablation of tumor with safety margin and occlusion of the 4th or 5th branches of portal vein. | Immediately after radiofrequency ablation (RFA) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiofrequency ablation, Gradual radiofrequency energy increment, Cone-unit ablation