NCT02683538

Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• Metastasis
• Cholangiocarcinoma

Interventions

Type	Name	Description
DEVICE	Separable cluster electrode (Octopus®)	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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-07-01
• Completion: 2014-07-01
• First posted: 2016-02-17
• Last updated: 2016-04-05

Locations

1 site across 1 country: South Korea