Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Separable clustered electrodes

• Registration Number: NCT02745483
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.

Detailed Description

Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome.

In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-16
• Last Update Submitted: 2016-04-16
• Study First Posted: 2016-04-20
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Separable clustered electrodes	Separable clustered electrodes	Enrolled patients in the prospective study (RFA using separable clustered electrodes (Octopus®)) for treatment-naive HCC (n=79)

Primary Outcome Measures

Name	Time	Method
Cumulative 3-year LTP rate	36 months after RFA	Comparison of rates of LTP in two groups in three years after RFA
Cumulative 2-year LTP rate	24 months after RFA	Comparison of rates of LTP in two groups in two years after RFA
Cumulative 1-year local tumor progression (LTP) rate	12 months after RFA	Comparison of rates of LTP in two groups in a year after RFA

Secondary Outcome Measures

Name	Time	Method
3-year Recurrence free survival rate	36 months after RFA	comparison of survival rate without disease progression in two groups
2-year Recurrence free survival rate	24 months after RFA	comparison of survival rate without disease progression in two groups
1-year Recurrence free survival rate	12 months after RFA	comparison of survival rate without disease progression in two groups

Trial Locations

Locations (1)

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