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Completed

NCT Number: NCT02745483

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Separable clustered electrodes

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.

Other names: Octopus®

Primary outcomes

  1. Cumulative 1-year local tumor progression (LTP) rate

    Time frame: 12 months after RFA

    Comparison of rates of LTP in two groups in a year after RFA

  2. Cumulative 2-year LTP rate

    Time frame: 24 months after RFA

    Comparison of rates of LTP in two groups in two years after RFA

  3. Cumulative 3-year LTP rate

    Time frame: 36 months after RFA

    Comparison of rates of LTP in two groups in three years after RFA

Secondary outcomes

  1. 1-year Recurrence free survival rate

    Time frame: 12 months after RFA

    comparison of survival rate without disease progression in two groups

  2. 2-year Recurrence free survival rate

    Time frame: 24 months after RFA

    comparison of survival rate without disease progression in two groups

  3. 3-year Recurrence free survival rate

    Time frame: 36 months after RFA

    comparison of survival rate without disease progression in two groups

Other outcomes

  1. Major complication rate after RFA

    Time frame: 30 days 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.

  2. Technical success rate

    Time frame: 1 day after RFA

    comparison of rates of sufficient ablative zone creation which covers the whole tumor on post-RFA computed tomography (CT) in each group

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2016
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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