Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.

Official Title
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Anatomical Radiofrequency Ablation for Peripherally Located Small Hepatocellular Carcinoma Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child-Pugh class A or B7. Presence of chronic hepatitis B or liver cirrhosis. Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines. Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System. Tumor location is less than 5 cm from liver capsule. Exclusion Criteria: The number of tumor is three or more. Tumor size is over 3 cm. Tumor location is over 5 cm from liver capsule. Child-Pugh class B8-9 or C. Presence of macrovascular invasion and/or distant metastasis. Platelet count < 50,000 mm3, or international normalized ratio > 1.5 (prothrombin time >1.5 × normal).

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 hepatocellular carcinoma (equal or less than 3 cm)<br>Under the guidance of multimodality-ultrasound (US) fusion image, one of the three electrodes was placed across the portal vein branch near the tumor, and the other two electrodes were placed around the tumor through the previously planned approach path. After placement of electrodes, the temperature is maintained at 90-100 degrees Celsius for about 6-30 minutes depending on the size of the tumor, using the combined energy transfer mode that sequentially adds the bipolar mode and/or the monopolar mode. | Procedure: Radiofrequency ablation<br>* Radiofrequency ablation is performed for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes. One of three electrodes is placed across the 4th or 5th portal vein branches near the target tumor which enables anatomical ablation of tumor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone. | Immediately after radiofrequency ablation | 
| Local tumor progression rate | Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success. | 12 months after radiofrequency ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication after radiofrequency ablation | Post-radiofrequency ablation complications were defined as problems noted within 1 month after RFA as well as additional complications identified on follow-up imaging and judged to be likely caused by radiofrequency ablation. | Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation | 
| Recurrence-free survival | Recurrence-free survival was defined as the interval between radiofrequency ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence. | 12 months after radiofrequency ablation |