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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DSM
SSM
Separable clustered electrodes
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring RFA

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 %)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RFA with DSM mode

RFA with SSM mode

Arm Description

RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

Outcomes

Primary Outcome Measures

Minimum diameter of ablative zone
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2018
Last Updated
March 18, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03699657
Brief Title
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2014 (Actual)
Primary Completion Date
April 11, 2018 (Actual)
Study Completion Date
June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
RFA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RFA with DSM mode
Arm Type
Active Comparator
Arm Description
RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
Arm Title
RFA with SSM mode
Arm Type
Active Comparator
Arm Description
RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
Intervention Type
Device
Intervention Name(s)
DSM
Intervention Description
Monopolar RFA using dual switching mode (DSM)
Intervention Type
Device
Intervention Name(s)
SSM
Intervention Description
Monopolar RFA using single switching mode (SSM)
Intervention Type
Device
Intervention Name(s)
Separable clustered electrodes
Other Intervention Name(s)
Octopus®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Minimum diameter of ablative zone
Description
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
Time Frame
7 days after RFA
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
Time Frame
1 month
Title
IDR rate
Description
Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA
Time Frame
24 months after RFA
Title
EM rate
Description
Cumulative extrahepatic metastasis (EM) rate over two years after RFA
Time Frame
24 months after RFA
Title
1-year local tumor progression (LTP)
Description
Comparison of rates of LTP in two groups in a year after RFA
Time Frame
12 months after RFA
Title
2-year LTP
Description
Comparison of rates of LTP in two groups in two years after RFA
Time Frame
24 months after RFA
Other Pre-specified Outcome Measures:
Title
Complication
Description
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.
Time Frame
1 month after RFA
Title
Volume of ablative zone
Description
Volume of ablative zone on post-RFA CT or MRI in a mm3.
Time Frame
7 days after RFA
Title
Ablation time
Description
RFA procedure time in each patient.
Time Frame
1 day
Title
Maximal diameter of ablative zone
Description
Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
Time Frame
7 days after RFA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 %)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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