Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

Phase 2

Completed

• Conditions: Metastasis; Cholangiocarcinoma; Hepatocellular Carcinoma
• Interventions: Device: Separable cluster electrode (Octopus®)

• Registration Number: NCT02683538
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2013-07
• Study Completion: 2014-07
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-17
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-02
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Separable cluster electrode	Separable cluster electrode (Octopus®)	radiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode.

Primary Outcome Measures

Name	Time	Method
Major complication rate after Radiofrequency ablation (RFA)	30 days after 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).

Secondary Outcome Measures

Name	Time	Method
Technical success	1 day after RFA	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.
Local control rate	12 months after RFA	Rate of local tumor progression after RFA

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of