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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bipolar RFA
SM-RFA
Twin internally cooled-wet electrodes
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:

  • 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 %)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TICW-RFA

SC-RFA

Arm Description

Bipolar RFA using twin internally cooled-wet electrodes

Switching monopolar RFA using separable clustered electrodes

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2019
Last Updated
April 3, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03806218
Brief Title
Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 16, 2015 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
February 12, 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 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.

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
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TICW-RFA
Arm Type
Active Comparator
Arm Description
Bipolar RFA using twin internally cooled-wet electrodes
Arm Title
SC-RFA
Arm Type
Active Comparator
Arm Description
Switching monopolar RFA using separable clustered electrodes
Intervention Type
Device
Intervention Name(s)
Bipolar RFA
Intervention Description
Bipolar RFA in which RF currents flow between two electrodes
Intervention Type
Device
Intervention Name(s)
SM-RFA
Intervention Description
Monopolar RFA using multiple electrodes with switching mode
Intervention Type
Device
Intervention Name(s)
Twin internally cooled-wet electrodes
Other Intervention Name(s)
CWTN-T
Intervention Description
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
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 ablation zone per unit time
Description
Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.
Time Frame
3 days after RFA
Secondary Outcome Measure Information:
Title
Technique efficacy
Description
Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
Time Frame
1 month after RFA
Title
IDR rate
Description
Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA
Time Frame
12 months, 24 months after RFA
Title
EM rate
Description
Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA
Time Frame
12 months, 24 months after RFA
Title
Local tumor progression (LTP)
Description
Cumulative LTP rates in two groups in 2 years after RFA
Time Frame
12 months, 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
3 days after RFA
Title
Ablation time
Description
RFA procedure time in each patient.
Time Frame
1 day

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: 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 %)
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
Citations:
PubMed Identifier
32986758
Citation
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.
Results Reference
derived

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

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