RFA for Small HCC With No-touch Technique Using Octopus Electrode

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

Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study

In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

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 1cm-2.5cm sized HCC
  • 1 or 2 HCCs
  • being referred for curative purpose of RFA
  • sign informed consent

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 using Octopus electrode and no touch technique.
Procedure: No-touch RFA
No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.
Active Comparator: Conventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique.
Procedure: Conventional tumor puncture RFA
Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

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)

October 21, 2016

Primary Completion (Actual)

September 11, 2018

Study Completion (Actual)

January 17, 2020

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 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-2016-2244

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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