Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

NCT ID: NCT02683538

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-07-31

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.

Conditions

Hepatocellular Carcinoma; Metastasis; Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Separable cluster electrode

radiofrequency ablation (RFA) using separable cluster electrode in switching monopolar mode.

Group Type: EXPERIMENTAL

Separable cluster electrode (Octopus®)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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 uncontrolled coagulopathy
• Patients with Child-Pugh classification C
• Patients with tumor invasion in major portal vein or hepatic vein branch
• Extrahepatic metastasis

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2011-0364

Identifier Type: -

Identifier Source: org_study_id