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

Seoul National University Hospital118 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

118

Conditions

Carcinoma, Hepatocellular

Interventions

No-touch RFAPROCEDURE

No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.

Conventional tumor puncture RFAPROCEDURE

Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

12 month local tumor progression (LTP) rate

Time frame: 12 month after RFA

Secondary Outcomes

tumor seeding rate

incidence of tract seeding after RFA.

Time frame: 12 months after RFA

Complication rate related with RFA

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

Time frame: 1 month

Technical success rate

presence or absence of residual lesion on follow-up imaging

Time frame: 1 months

Data from ClinicalTrials.gov

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