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

Hepatocellular Carcinoma Clinical Trial

Official title:

Prospective, Single-center, Single-arm, Clinical Trial Evaluating the Clinical Efficacy and Safety of a Novel Separable Cluster Electrode in Patients With Focal Liver Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745483
• Other study ID #: SNUH-2016-0486
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2016
• Last updated: April 16, 2016
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion criteria

• HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines

• 1-3 HCCs equal to or smaller than 5cm in the liver

• no direct contact with or invasion into the hepatic hilar structures or inferior vena cava

• treatment-naive HCC

Exclusion criteria

• patients with uncontrolled coagulopathy

• patients with Child-Pugh classification C

• patients with tumor invasion into the portal vein or hepatic vein

• extrahepatic spread

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• Separable clustered electrodes
patients who signed informed consent, RFA was performed using separable clustered electrodes (Octopus®) in which, inter-tine distances can be flexibly adjusted by an operator.

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	Major complication rate after RFA	Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.	30 days after RFA	Yes
Other	Technical success rate	comparison of rates of sufficient ablative zone creation which covers the whole tumor on post-RFA computed tomography (CT) in each group	1 day after RFA	No
Primary	Cumulative 1-year local tumor progression (LTP) rate	Comparison of rates of LTP in two groups in a year after RFA	12 months after RFA	No
Primary	Cumulative 2-year LTP rate	Comparison of rates of LTP in two groups in two years after RFA	24 months after RFA	No
Primary	Cumulative 3-year LTP rate	Comparison of rates of LTP in two groups in three years after RFA	36 months after RFA	No
Secondary	1-year Recurrence free survival rate	comparison of survival rate without disease progression in two groups	12 months after RFA	No
Secondary	2-year Recurrence free survival rate	comparison of survival rate without disease progression in two groups	24 months after RFA	No
Secondary	3-year Recurrence free survival rate	comparison of survival rate without disease progression in two groups	36 months after RFA	No