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Completed

NCT Number: NCT02683538

Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Separable cluster electrode (Octopus®)

Device

Patients undergo RFA under ultrasound guidance, and separable cluster electrodes are used for RFA in monopolar switching mode, using multiple overlapping technique to create larger ablative zones.

Primary outcomes

  1. Major complication rate after Radiofrequency ablation (RFA)

    Time frame: 30 days after RFA

    Rates of major complication according to Society of Interventional Radiology (SIR) grading system, which refers to an event that leads to substantial morbidity and disability (SIR classification C-E).

Secondary outcomes

  1. Technical success

    Time frame: 1 day after RFA

    Technical success addresses that the tumor was treated according to protocol and completely covered by ablative zone on pre-RFA image and post-RFA image side-by-side comparison.

  2. Local control rate

    Time frame: 12 months after RFA

    Rate of local tumor progression after RFA

Other outcomes

  1. total procedure time

    Time frame: 1 day after RFA

    total procedure time per patients was recorded.

  2. Ablative zone volume

    Time frame: 1 day after RFA

    ablative zone volume measurement for each tumor on post-RFA cross sectional imaging

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 17, 2016
Registry last updated
Apr 5, 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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