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

Seoul National University

Status: Unknown

Conditions: Carcinoma, Hepatocellular

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02806076

SNUH-2016-2243

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

No-touch RFA arm

Experimental group

Description:

No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Treatment:

Procedure: No-touch RFA arm

Conventional tumor puncture RFA arm

Active Comparator group

Description:

Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

Treatment:

Procedure: Conventional tumor puncture RFA arm