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

Not Applicable

Completed

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

• Registration Number: NCT02832882
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Study Start: 2016-10-21
• Primary Completion: 2018-09-11
• Study Completion: 2020-01-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-touch RFA arm	No-touch RFA	No-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique.
Conventional tumor puncture RFA arm	Conventional tumor puncture RFA	Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique.

Primary Outcome Measures

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

Secondary Outcome Measures

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