Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique
1 other identifier
interventional
140
1 country
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Nov 2017
5 active sites
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
Study Start
First participant enrolled
November 20, 2017
CompletedFirst Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2020
CompletedMarch 23, 2021
March 1, 2021
2.2 years
December 12, 2017
March 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
1 year local tumor progression
cumulative incidence of local tumor progression after RFA
1 year after procedure
Study Arms (1)
No touch group
EXPERIMENTALRFA for small HCC would be done by using no touch technique
Interventions
Eligibility Criteria
You may qualify if:
- Child-Pugh class A liver function
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Starmedcollaborator
Study Sites (5)
Asan medical Center
Seoul, 05505, South Korea
Samsung medical center
Seoul, 06351, South Korea
KonKuk university hospital
Seoul, South Korea
Saint Mary Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 34313474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, M.D.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 18, 2017
Study Start
November 20, 2017
Primary Completion
January 28, 2020
Study Completion
August 21, 2020
Last Updated
March 23, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share