Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Device: Separable clustered electrodes

Study type: Interventional

Funder types: Other

Identifiers

NCT02745483

SNUH-2016-0486

Details and patient eligibility

About

The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.

Full description

Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome.

In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.

Enrollment: 153 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines
• 1-3 HCCs equal to or smaller than 5cm in the liver
• no direct contact with or invasion into the hepatic hilar structures or inferior vena cava
• treatment-naive HCC

Exclusion criteria

• patients with uncontrolled coagulopathy
• patients with Child-Pugh classification C
• patients with tumor invasion into the portal vein or hepatic vein
• extrahepatic spread

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Separable clustered electrodes

Experimental group

Description:

Enrolled patients in the prospective study (RFA using separable clustered electrodes (Octopus®)) for treatment-naive HCC (n=79)

Treatment:

Device: Separable clustered electrodes

Historical control group

No Intervention group

Description:

Patients who received RFA according to routine protocol in our center (multiple internally-cooled electrodes) for treatment-naive HCC from Jan 2011 to July 2013 in our institution (n=74) .