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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: Separable clustered electrodes; Device: Bipolar RFA; Device: Twin internally cooled-wet electrodes; Device: SM-RFA

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TICW-RFA; Bipolar RFA using twin internally cooled-wet electrodes	Device: Bipolar RFA; Bipolar RFA in which RF currents flow between two electrodes; Device: Twin internally cooled-wet electrodes; 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; Other Names: CWTN-T
Active Comparator: SC-RFA; Switching monopolar RFA using separable clustered electrodes	Device: Separable clustered electrodes; 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.; Other Names: Octopus®; Device: SM-RFA; Monopolar RFA using multiple electrodes with switching mode

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.	1 month after RFA
Ablation time	RFA procedure time in each patient.	1 day
Volume of ablative zone	Volume of ablative zone on post-RFA CT or MRI in a mm3	3 days after RFA

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. 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. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2015
• Primary Completion (Actual): May 16, 2018
• Study Completion (Actual): February 12, 2019

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: RFA
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: SNUH-2015-0401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO