Clinical trial NCT02683538: Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies
Official title: Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Metastasis
Cholangiocarcinoma
Keywords: RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 196
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Major complication rate after Radiofrequency ablation (RFA)
timeFrame: 30 days after RFA
Secondary outcomes:
measure: Technical success
timeFrame: 1 day after RFA
measure: Local control rate
timeFrame: 12 months after RFA
Other outcomes:
measure: total procedure time
timeFrame: 1 day after RFA
measure: Ablative zone volume
timeFrame: 1 day after RFA
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: