Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC

March 18, 2020 updated by: Jeong Min Lee, Seoul National University Hospital

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA.

Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Diagnosed with HCC (>= 1.5cm and < 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
  • no history of previous locoregional treatment

Exclusion Criteria:

  • more than three HCC nodules
  • tumors abutting to the central portal vein or hepatic vein with a diameter > 5 mm
  • Child-Pugh class C
  • tumors with major vascular invasion
  • extrahepatic metastasis
  • severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: RFA with DSM mode
RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
Device: DSM
Monopolar RFA using dual switching mode (DSM)
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®
ACTIVE_COMPARATOR: RFA with SSM mode
RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
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: SSM
Monopolar RFA using single switching mode (SSM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum diameter of ablative zone
Time Frame: 7 days after RFA
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
7 days after RFA

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: 1 month after RFA
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
Volume of ablative zone
Time Frame: 7 days after RFA
Volume of ablative zone on post-RFA CT or MRI in a mm3.
7 days after RFA
Ablation time
Time Frame: 1 day
RFA procedure time in each patient.
1 day
Maximal diameter of ablative zone
Time Frame: 7 days after RFA
Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
7 days after RFA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2014

Primary Completion (ACTUAL)

April 11, 2018

Study Completion (ACTUAL)

June 19, 2019

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2014-0279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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