Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

Hepatocellular Carcinoma Clinical Trial

Official title:

Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683538
• Other study ID #: 2011-0364
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2016
• Last updated: April 2, 2016
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Metastasis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	total procedure time	total procedure time per patients was recorded.	1 day after RFA	No
Other	Ablative zone volume	ablative zone volume measurement for each tumor on post-RFA cross sectional imaging	1 day after RFA	No
Primary	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).	30 days after RFA	Yes
Secondary	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.	1 day after RFA	No
Secondary	Local control rate	Rate of local tumor progression after RFA	12 months after RFA	No