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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Bipolar RFA; Device: SM-RFA; Device: Separable clustered electrodes; Device: Twin internally cooled-wet electrodes

• Registration Number: NCT03806218
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-16
• Primary Completion: 2018-05-16
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Completion: 2019-02-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 %)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TICW-RFA	Bipolar RFA	Bipolar RFA using twin internally cooled-wet electrodes
SC-RFA	SM-RFA	Switching monopolar RFA using separable clustered electrodes
SC-RFA	Separable clustered electrodes	Switching monopolar RFA using separable clustered electrodes
TICW-RFA	Twin internally cooled-wet electrodes	Bipolar RFA using twin internally cooled-wet electrodes

Primary Outcome Measures

Name	Time	Method
Minimum diameter of ablation zone per unit time	3 days after RFA	Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of