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

NCT ID: NCT02745483

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

Separable clustered electrodes

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

Group Type: EXPERIMENTAL

Separable clustered electrodes

Intervention Type: DEVICE

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.

Historical control group

Patients who received RFA according to routine protocol in our center (multiple internally-cooled electrodes) for treatment-naive HCC from Jan 2011 to July 2013 in our institution (n=74) .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Octopus®

Eligibility Criteria

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

• 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

References

Choi JW, Lee JM, Lee DH, Yoon JH, Suh KS, Yoon JH, Kim YJ, Lee JH, Yu SJ, Han JK. Switching Monopolar Radiofrequency Ablation Using a Separable Cluster Electrode in Patients with Hepatocellular Carcinoma: A Prospective Study. PLoS One. 2016 Aug 30;11(8):e0161980. doi: 10.1371/journal.pone.0161980. eCollection 2016.

Reference Type: DERIVED

PMID: 27575787 (View on PubMed)

Other Identifiers

SNUH-2016-0486

Identifier Type: -

Identifier Source: org_study_id