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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02806076

Collaborator

(none)

100

Enrollment

Location

Arms

92.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Procedure: No-touch RFA arm Procedure: Conventional tumor puncture RFA arm	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

12 month local tumor progression (LTP) rate [12 months after RFA]

Secondary Outcome Measures

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

Other Outcome Measures

Ablation time [3 days after RFA]
ablation time for tumor ablation
Intrahepatic distant mets [12 months after RFA]
incidence of intrahepatic distant metastasis after RFA
Extrahepatic distant mets [12 months after RFA]
incidence of extrahepatic distant metastasis after RFA
Technical efficacy 1 [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
Technical efficacy 2 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02806076

Other Study ID Numbers:

SNUH-2016-2243

First Posted:

Jun 20, 2016

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital

HCC

RFA

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Mar 19, 2021