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Completed

NCT Number: NCT03699657

Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC

This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA.

Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with HCC (>= 1.5cm and < 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
  • no history of previous locoregional treatment

Exclusion criteria

  • more than three HCC nodules
  • tumors abutting to the central portal vein or hepatic vein with a diameter > 5 mm
  • Child-Pugh class C
  • tumors with major vascular invasion
  • extrahepatic metastasis
  • severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)

Treatment and study plan

DSM

Device

Monopolar RFA using dual switching mode (DSM)

SSM

Device

Monopolar RFA using single switching mode (SSM)

Separable clustered electrodes

Device

A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.

Other names: Octopus®

Primary outcomes

  1. Minimum diameter of ablative zone

    Time frame: 7 days after RFA

    Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.

Secondary outcomes

  1. Technical success rate

    Time frame: 1 month

    Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)

  2. IDR rate

    Time frame: 24 months after RFA

    Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA

  3. EM rate

    Time frame: 24 months after RFA

    Cumulative extrahepatic metastasis (EM) rate over two years after RFA

  4. 1-year local tumor progression (LTP)

    Time frame: 12 months after RFA

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

  5. 2-year LTP

    Time frame: 24 months after RFA

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

Other outcomes

  1. Complication

    Time frame: 1 month 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. Volume of ablative zone

    Time frame: 7 days after RFA

    Volume of ablative zone on post-RFA CT or MRI in a mm3.

  3. Ablation time

    Time frame: 1 day

    RFA procedure time in each patient.

  4. Maximal diameter of ablative zone

    Time frame: 7 days after RFA

    Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Mar 20, 2020

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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