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

March 19, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique: A Prospective Single Arm Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Konkuk University Hospital
      • Seoul, Korea, Republic of
        • Saint Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No touch group
RFA for small HCC would be done by using no touch technique
Procedure: RFA
thermal ablation using radiofrequency for HCC

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Starmed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

January 28, 2020

Study Completion (Actual)

August 21, 2020

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2017-0870

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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