RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode
Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMarch 19, 2021
March 1, 2021
5.7 years
June 3, 2016
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12 month local tumor progression (LTP) rate
12 months after RFA
Secondary Outcomes (3)
2. tumor seeding rate
12 months after RFA
Complication rate related with RFA
1 month after RFA
Technical success rate
1 month after RFA
Other Outcomes (5)
Ablation time
3 days after RFA
Intrahepatic distant mets
12 months after RFA
Extrahepatic distant mets
12 months after RFA
- +2 more other outcomes
Study Arms (2)
No-touch RFA arm
EXPERIMENTALNo-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
Conventional tumor puncture RFA arm
ACTIVE COMPARATORConventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.
Interventions
Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
Eligibility Criteria
You may qualify if:
- Child-Pugh class A
- patient with 1-2.5cm sized HCC
- or 2 HCC lesions
You may not qualify if:
- maximum tumor diameter greater than 2.5cm
- Child-Pugh class B or C
- more than 3 HCC lesions
- invisible tumor even after US/CT or US/MR fusion
- presence of vascular tumor thrombosis or extrahepatic metastasis
- severe coagulopathy (PLT \< 50K, PT \< 50% of normal range)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 3, 2016
First Posted
June 20, 2016
Study Start
July 1, 2016
Primary Completion
March 30, 2022
Study Completion
March 30, 2024
Last Updated
March 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share