Back to resultsRadiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique
Primary Purpose
Hepatocellular Carcinoma, Radiofrequency Ablation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RFA
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Child-Pugh class A liver function
- 1 - 2.5 cm sized Single nodular HCC
- without history of previous HCC treatment or with evidence of no recurrence at least 2 years after previous HCC treatment
Exclusion Criteria:
- more than 2 HCC
- tumor size larger than 2.5 cm
- Child-Pugh class B or C liver function
- invisible tumor even after real-time fusion US guidance
- accompanied by vascular invasion or distant metastasis
- presence of coagulopathy defined as platelet count < 50,000/mm3 and/or PT-INR > 50%
Sites / Locations
- Asan medical Center
- Samsung medical center
- KonKuk university hospital
- Saint Mary Hospital
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
No touch group
Arm Description
RFA for small HCC would be done by using no touch technique
Outcomes
Primary Outcome Measures
1 year local tumor progression
cumulative incidence of local tumor progression after RFA
Secondary Outcome Measures
Full Information
NCT ID
NCT03375281
First Posted
December 12, 2017
Last Updated
March 19, 2021
Sponsor
Seoul National University Hospital
Collaborators
starmed
1. Study Identification
Unique Protocol Identification Number
NCT03375281
Brief Title
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique
Official Title
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique: A Prospective Single Arm Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
August 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
starmed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC using no touch technique with separable clustered electrode (Octopus) in a prospective multicenter manner Participating center: Seoul national university hospital, Asan medical center, Samsung medical center, Kunkuk university hospital, St. mary's Seoul hospital
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Radiofrequency Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No touch group
Arm Type
Experimental
Arm Description
RFA for small HCC would be done by using no touch technique
Intervention Type
Procedure
Intervention Name(s)
RFA
Intervention Description
thermal ablation using radiofrequency for HCC
Primary Outcome Measure Information:
Title
1 year local tumor progression
Description
cumulative incidence of local tumor progression after RFA
Time Frame
1 year after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child-Pugh class A liver function
1 - 2.5 cm sized Single nodular HCC
without history of previous HCC treatment or with evidence of no recurrence at least 2 years after previous HCC treatment
Exclusion Criteria:
more than 2 HCC
tumor size larger than 2.5 cm
Child-Pugh class B or C liver function
invisible tumor even after real-time fusion US guidance
accompanied by vascular invasion or distant metastasis
presence of coagulopathy defined as platelet count < 50,000/mm3 and/or PT-INR > 50%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
KonKuk university hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Saint Mary Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34313474
Citation
Lee DH, Lee MW, Kim PN, Lee YJ, Park HS, Lee JM. Outcome of No-Touch Radiofrequency Ablation for Small Hepatocellular Carcinoma: A Multicenter Clinical Trial. Radiology. 2021 Oct;301(1):229-236. doi: 10.1148/radiol.2021210309. Epub 2021 Jul 27.
Results Reference
derived
Learn more about this trial
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique
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