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

Seoul National University

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Procedure: No-touch RFA; Procedure: Conventional tumor puncture RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT02832882

SNUH-2016-2244

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

No-touch RFA arm

Experimental group

Description:

No-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique.

Treatment:

Procedure: No-touch RFA

Conventional tumor puncture RFA arm

Active Comparator group

Description:

Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique.

Treatment:

Procedure: Conventional tumor puncture RFA