Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

Seoul National University Hospital196 enrolled

Overview

The purpose of this study is to evaluate the clinical feasibility and short-term outcome of switching monopolar RFA using a separable cluster electrode in patients with primary and secondary liver malignancies.

Radiofrequency ablation (RFA) is one of minimal invasive treatment methods and it has been showing comparable overall survival with surgery in early or small hepatocellular carcinomas (HCCs) and better cost-effectiveness. However, it is suffering from high local tumor progression (LTP) rate. To reduce LTP rate, creation of large ablative zone has been attempted in various strategies. A separable cluster electrode is a new type of RFA electrode. It consists of three individual applicators and the applicators can be incorporated as a single handle such as a cluster electrode, and can be separated as three electrodes, depending on operators' needs. It allows high flexibility to operators and the preclinical results were promising. Herein, we want to evaluate the clinical feasibility of the electrodes by observing major complication rates, technical success rate and 12-months LTP rate.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

196

Conditions

Hepatocellular Carcinoma Metastasis Cholangiocarcinoma

Interventions

Separable cluster electrode (Octopus®)DEVICE

Patients undergo RFA under ultrasound guidance, and separable cluster electrodes are used for RFA in monopolar switching mode, using multiple overlapping technique to create larger ablative zones.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hepatic malignancies diagnosed on biopsy OR * Typical imaging features of hepatocellular carcinoma (HCC) on computed tomography (CT) or magnetic resonance imaging (MRI) according to AASLD guideline * Typical imaging feature of metastasis on CT or MRI AND * 1\~5 tumors equal to or smaller than 5cm in the liver * no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (IVC) * Eastern Cooperative Oncology Group performance status of 0 * Patients who signed informed consent Exclusion Criteria: Patients with any of followings are excluded. * Patients with uncontrolled coagulopathy * Patients with Child-Pugh classification C * Patients with tumor invasion in major portal vein or hepatic vein branch * Extrahepatic metastasis

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Major complication rate after Radiofrequency ablation (RFA)

Rates of major complication according to Society of Interventional Radiology (SIR) grading system, which refers to an event that leads to substantial morbidity and disability (SIR classification C-E).

Time frame: 30 days after RFA

Secondary Outcomes

Technical success

Technical success addresses that the tumor was treated according to protocol and completely covered by ablative zone on pre-RFA image and post-RFA image side-by-side comparison.

Time frame: 1 day after RFA

Local control rate

Rate of local tumor progression after RFA

Time frame: 12 months after RFA

Data from ClinicalTrials.gov

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