Radiofrequency Ablation Using Octopus Electrodes for Smal... | NCT03375281

Studies
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique

NCT03375281

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 23, 2021Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma
Radiofrequency Ablation

Interventions

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2017Actual

Primary Completion Date

Jan 28, 2020Actual

Completion Date

Aug 21, 2020Actual

First Submitted Date

Dec 12, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2021

Last Update Posted Date

Mar 23, 2021Actual

Name	Class
Starmed	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No touch group	Experimental	RFA for small HCC would be done by using no touch technique	Procedure: RFA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RFA	Procedure	thermal ablation using radiofrequency for HCC	No touch group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1 year local tumor progression	cumulative incidence of local tumor progression after RFA	1 year after procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeong Min Lee, M.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan medical Center		Seoul		05505	South Korea
Samsung medical center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34313474	Derived	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.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type