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Completed

NCT Number: NCT03806218

Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC

This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
  • HCC nodules measuring 1 cm or larger and smaller than 5 cm

Exclusion criteria

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

Treatment and study plan

Bipolar RFA

Device

Bipolar RFA in which RF currents flow between two electrodes

SM-RFA

Device

Monopolar RFA using multiple electrodes with switching mode

Twin internally cooled-wet electrodes

Device

Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity

Other names: CWTN-T

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 ablation zone per unit time

    Time frame: 3 days after RFA

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

Secondary outcomes

  1. Technique efficacy

    Time frame: 1 month after RFA

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

  2. IDR rate

    Time frame: 12 months, 24 months after RFA

    Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA

  3. EM rate

    Time frame: 12 months, 24 months after RFA

    Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA

  4. Local tumor progression (LTP)

    Time frame: 12 months, 24 months after RFA

    Cumulative LTP rates in two groups in 2 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: 3 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Apr 7, 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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