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

Primary Purpose

Carcinoma, Hepatocellular

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

No-touch RFA arm

Conventional tumor puncture RFA arm

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HCC, RFA

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No-touch RFA arm

Conventional tumor puncture RFA arm

Arm Description

No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

Outcomes

Primary Outcome Measures

12 month local tumor progression (LTP) rate

Secondary Outcome Measures

2. tumor seeding rate

Complication rate related with RFA

RFA-related complication rate such as death, abscess, bleeding..etc.

Technical success rate

presence or absence of residual lesion on follow-up imaging

Full Information

NCT ID

NCT02806076

First Posted

June 3, 2016

Last Updated

March 17, 2021

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02806076

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

March 30, 2022 (Anticipated)

Study Completion Date

March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

Keywords

HCC, RFA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No-touch RFA arm

Arm Type

Experimental

Arm Description

No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Arm Title

Conventional tumor puncture RFA arm

Arm Type

Active Comparator

Arm Description

Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

Intervention Type

Procedure

Intervention Name(s)

No-touch RFA arm

Intervention Description

No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Intervention Type

Procedure

Intervention Name(s)

Conventional tumor puncture RFA arm

Intervention Description

Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

Primary Outcome Measure Information:

Title

12 month local tumor progression (LTP) rate

Time Frame

12 months after RFA

Secondary Outcome Measure Information:

Title

2. tumor seeding rate

Time Frame

12 months after RFA

Title

Complication rate related with RFA

Description

RFA-related complication rate such as death, abscess, bleeding..etc.

Time Frame

1 month after RFA

Title

Technical success rate

Description

presence or absence of residual lesion on follow-up imaging

Time Frame

1 month after RFA

Other Pre-specified Outcome Measures:

Title

Ablation time

Description

ablation time for tumor ablation

Time Frame

3 days after RFA

Title

Intrahepatic distant mets

Description

incidence of intrahepatic distant metastasis after RFA

Time Frame

12 months after RFA

Title

Extrahepatic distant mets

Description

incidence of extrahepatic distant metastasis after RFA

Time Frame

12 months after RFA

Title

Technical efficacy 1

Description

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

Time Frame

2 days after RFA

Title

Technical efficacy 2

Description

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

Time Frame

2 days after RFA

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun Hee Lee, RN

Phone

82-2-2072-4177

redlion55@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeong Min Lee, MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeong Min Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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