Back to resultsMonopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)
Primary Purpose
HCC, Metastasis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DSM
separable clustered electrode
Sponsored by
About this trial
This is an interventional treatment trial for HCC focused on measuring RFA
Eligibility Criteria
Inclusion Criteria:
- Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
- histologically confirmed HCC
- histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
- equal to or larger than 2cm, equal to or smaller than 5cm
- available cross-sectional liver imaging within 30 days before RFA
- signed informed consent
Exclusion Criteria:
- history of local treatment on the index tumor
- more than three tumors in a patient
- tumors in central portion of portal vein or hepatic vein
- Child-Pugh class C
- vascular invasion by tumors
- uncorrected coagulopathy
- presence of multiple extrahepatic metastases
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
RFA DSM
RFA SSM
Arm Description
Eligible patients who undergo RFA using DSM and separable clustered electrodes.
Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.
Outcomes
Primary Outcome Measures
local tumor progression (LTP)
Secondary Outcome Measures
Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)
rate of intrahepatic distant recurrence (IDR) after RFA
rate of extrahepatic metastasis (EM) after RFA
Full Information
NCT ID
NCT02675881
First Posted
January 31, 2016
Last Updated
March 17, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02675881
Brief Title
Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)
Official Title
Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2013 (Actual)
Primary Completion Date
April 8, 2015 (Actual)
Study Completion Date
July 13, 2015 (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
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.
Detailed Description
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC, Metastasis
Keywords
RFA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA DSM
Arm Type
Active Comparator
Arm Description
Eligible patients who undergo RFA using DSM and separable clustered electrodes.
Arm Title
RFA SSM
Arm Type
No Intervention
Arm Description
Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.
Intervention Type
Device
Intervention Name(s)
DSM
Intervention Description
Monopolar RFA using dual switching mode (DSM)
Intervention Type
Device
Intervention Name(s)
separable clustered electrode
Other Intervention Name(s)
Octopus(R)
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
local tumor progression (LTP)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)
Time Frame
1 months
Title
rate of intrahepatic distant recurrence (IDR) after RFA
Time Frame
12 months
Title
rate of extrahepatic metastasis (EM) after RFA
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Number of complication of RFA
Description
incidence of any possible complication related with RFA
Time Frame
6 months
Title
Maximal diameter of ablative zone
Description
Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
Time Frame
7 day
Title
ablation time
Description
ablation time in a patient
Time Frame
1 day
Title
Real time US fusion image feasibility
Description
success or failure of accurate fusion between US and pre-RFA cross sectional images
Time Frame
1 day after RFA procedure
Title
Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration.
Description
Prediction of LTP by classifying patients according to assessing ablative margin in each method on a four point scale (1: residual tumor, 4: ablative margin equal to or larger than 5mm)
Time Frame
12 months
Title
Volume of ablative zone
Description
Volume of ablative zone on post-RFA CT or MRI in a mm3.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
histologically confirmed HCC
histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
equal to or larger than 2cm, equal to or smaller than 5cm
available cross-sectional liver imaging within 30 days before RFA
signed informed consent
Exclusion Criteria:
history of local treatment on the index tumor
more than three tumors in a patient
tumors in central portion of portal vein or hepatic vein
Child-Pugh class C
vascular invasion by tumors
uncorrected coagulopathy
presence of multiple extrahepatic metastases
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
Yes
Learn more about this trial
Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)
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