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

Not Applicable

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: No-touch RFA arm; Procedure: Conventional tumor puncture RFA arm

• Registration Number: NCT02806076
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-07-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19
• Primary Completion: 2022-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-touch RFA arm	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.
Conventional tumor puncture RFA arm	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.

Primary Outcome Measures

Name	Time	Method
12 month local tumor progression (LTP) rate	12 months after RFA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of