RFA for Small HCC With No-touch Technique Using Octopus Electrode

Study Overview
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Brief Summary
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In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.

Official Title
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Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study

Conditions
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Carcinoma, Hepatocellular

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child-Pugh class A patient with 1cm-2.5cm sized HCC 1 or 2 HCCs being referred for curative purpose of RFA sign informed consent 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 using Octopus electrode and no touch technique. | Procedure: No-touch RFA<br>* No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.<br>|
| Active Comparator: Conventional tumor puncture RFA arm<br>Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique. | Procedure: Conventional tumor puncture RFA<br>* Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.<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 month after RFA | 

Secondary Outcome Measures

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

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