RFA for Small HCC With No-touch Technique Using Octopus Electrode
Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study
1 other identifier
interventional
118
0 countries
N/A
Brief Summary
In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.
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 Oct 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedStudy Start
First participant enrolled
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedMarch 22, 2021
March 1, 2021
1.9 years
June 3, 2016
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12 month local tumor progression (LTP) rate
12 month after RFA
Secondary Outcomes (3)
tumor seeding rate
12 months after RFA
Complication rate related with RFA
1 month
Technical success rate
1 months
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 using Octopus electrode and no touch technique.
Conventional tumor puncture RFA arm
ACTIVE COMPARATORConventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique.
Interventions
No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.
Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.
Eligibility Criteria
You may qualify if:
- Child-Pugh class A
- patient with 1cm-2.5cm sized HCC
- or 2 HCCs
- being referred for curative purpose of RFA
- sign informed consent
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
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
July 14, 2016
Study Start
October 21, 2016
Primary Completion
September 11, 2018
Study Completion
January 17, 2020
Last Updated
March 22, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share