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

Seoul National University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Device: SM-RFA; Device: Separable clustered electrodes; Device: Bipolar RFA; Device: Twin internally cooled-wet electrodes

Study type: Interventional

Funder types: Other

Identifiers

NCT03806218

SNUH-2015-0401

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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 %)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups

TICW-RFA

Active Comparator group

Description:

Bipolar RFA using twin internally cooled-wet electrodes

Treatment:

Device: Twin internally cooled-wet electrodes

Device: Bipolar RFA

SC-RFA

Active Comparator group

Description:

Switching monopolar RFA using separable clustered electrodes

Treatment:

Device: Separable clustered electrodes

Device: SM-RFA