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

NCT ID: NCT03375281

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2020-08-21

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma Radiofrequency Ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No touch group

RFA for small HCC would be done by using no touch technique

Group Type EXPERIMENTAL

RFA

Intervention Type PROCEDURE

thermal ablation using radiofrequency for HCC

Interventions

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RFA

thermal ablation using radiofrequency for HCC

Intervention Type PROCEDURE

Eligibility Criteria

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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%
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Starmed

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Asan medical Center

Seoul, , South Korea

Site Status

Samsung medical center

Seoul, , South Korea

Site Status

KonKuk university hospital

Seoul, , South Korea

Site Status

Saint Mary Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 34313474 (View on PubMed)

Other Identifiers

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SNUH-2017-0870

Identifier Type: -

Identifier Source: org_study_id

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