Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC

Study Overview
=================
Brief Summary
-----------------
This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.

Official Title
-----------------
Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: Bipolar RFA
* Device: SM-RFA
* Device: Twin internally cooled-wet electrodes
* Device: Separable clustered electrodes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment HCC nodules measuring 1 cm or larger and smaller than 5 cm Exclusion Criteria: more than three HCC nodules tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter > 5mm extrahepatic metastasis Child-Pugh class C severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TICW-RFA<br>Bipolar RFA using twin internally cooled-wet electrodes | Device: Bipolar RFA<br>* Bipolar RFA in which RF currents flow between two electrodes<br>Device: Twin internally cooled-wet electrodes<br>* Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity<br>* Other names: CWTN-T;|
| Active Comparator: SC-RFA<br>Switching monopolar RFA using separable clustered electrodes | Device: SM-RFA<br>* Monopolar RFA using multiple electrodes with switching mode<br>Device: Separable clustered electrodes<br>* A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.<br>* Other names: Octopus®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum diameter of ablation zone per unit time | Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm. | 3 days after RFA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technique efficacy | Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor) | 1 month after RFA | 
| IDR rate | Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA | 12 months, 24 months after RFA | 
| EM rate | Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA | 12 months, 24 months after RFA | 
| Local tumor progression (LTP) | Cumulative LTP rates in two groups in 2 years after RFA | 12 months, 24 months after RFA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RFA