RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode

Study Overview
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Brief Summary
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The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.

Official Title
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Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Procedure: No-touch RFA arm
* Procedure: Conventional tumor puncture RFA arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child-Pugh class A patient with 1-2.5cm sized HCC 1 or 2 HCC lesions Exclusion Criteria: maximum tumor diameter greater than 2.5cm Child-Pugh class B or C more than 3 HCC lesions invisible tumor even after US/CT or US/MR fusion presence of vascular tumor thrombosis or extrahepatic metastasis severe coagulopathy (PLT < 50K, PT < 50% of normal range)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No-touch RFA arm<br>No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode. | Procedure: No-touch RFA arm<br>* No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.<br>|
| Active Comparator: Conventional tumor puncture RFA arm<br>Conventional tumor puncture RFA arm indicates RFA procedure using conventional tumor puncture technique. In this study, RFA is done by using dual cooled electrode. | Procedure: Conventional tumor puncture RFA arm<br>* Conventional tumor puncture RFA arm indicates RFA procedure using conventional tumor puncture technique. In this study, RFA is done by using dual cooled electrode.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 month local tumor progression (LTP) rate |  | 12 months after RFA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. tumor seeding rate |  | 12 months after RFA | 
| Complication rate related with RFA | RFA-related complication rate such as death, abscess, bleeding..etc. | 1 month after RFA | 
| Technical success rate | presence or absence of residual lesion on follow-up imaging | 1 month after RFA | 

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