RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode

March 17, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study

The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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
        • Recruiting
        • Seoul National University 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
  • patient with 1-2.5cm sized HCC
  • 1 or 2 HCC lesions

Exclusion Criteria:

  • 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)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No-touch RFA arm
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
Procedure: No-touch RFA arm
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
Active Comparator: Conventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.
Procedure: Conventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12 month local tumor progression (LTP) rate
Time Frame: 12 months after RFA
12 months after RFA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. tumor seeding rate
Time Frame: 12 months after RFA
12 months after RFA
Complication rate related with RFA
Time Frame: 1 month after RFA
RFA-related complication rate such as death, abscess, bleeding..etc.
1 month after RFA
Technical success rate
Time Frame: 1 month after RFA
presence or absence of residual lesion on follow-up imaging
1 month after RFA

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation time
Time Frame: 3 days after RFA
ablation time for tumor ablation
3 days after RFA
Intrahepatic distant mets
Time Frame: 12 months after RFA
incidence of intrahepatic distant metastasis after RFA
12 months after RFA
Extrahepatic distant mets
Time Frame: 12 months after RFA
incidence of extrahepatic distant metastasis after RFA
12 months after RFA
Technical efficacy 1
Time Frame: 2 days after RFA
Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using visual assessment
2 days after RFA
Technical efficacy 2
Time Frame: 2 days after RFA
Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using registration software
2 days after RFA

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

July 1, 2016

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2016-2243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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