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Completed

NCT Number: NCT02675894

Radiofrequency Ablation Using Cooled-Wet Electrode

To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.

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Key information

Conditions

HCC Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

all conditions have to be fulfilled.

  • Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
  • liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
  • signed informed consent
  • treatment naive index tumor (no history of local treatment for an index tumor)

Exclusion criteria

  • more than three tumors in a patients
  • tumor size larger than 5cm
  • tumor attaches to central portal vein or hepatic vein
  • Child-Pugh classification C
  • uncorrected coagulopathy
  • presence of extrahepatic metastases

Treatment and study plan

cooled-wet electrode

Device

RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.

separable clustered electrode

Device

RFA is performed using separable clustered electrode in switching monopolar mode.

Other names: Octopus(R)

Primary outcomes

  1. LTP

    Time frame: 24 months

    cumulating local tumor progression rate over 2- year after RFA

Secondary outcomes

  1. Technical success rate

    Time frame: 1 months

    technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)

  2. IDR rate

    Time frame: 24 months

    cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA

  3. EM rate

    Time frame: 24 months

    cumulating extrahepatic metastasis (EM) rate over 2- year after RFA

  4. Maximal diameter of ablative zone

    Time frame: 7 day

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

  5. ablation time

    Time frame: 1 day

    RFA procedure time in each patient.

  6. Complication

    Time frame: 12 months

    all complication rate and grades (according to Clavien system from I to III) related with RFA procedure

  7. Volume of ablative zone

    Time frame: 7 days

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

Other outcomes

  1. US/CT or MR fusion success rate

    Time frame: 1 day

    RFA is performed under real time US guidance and US is fused with pre-RFA CT or MRI before ablation of the index tumor. US/CT or US/MR fusion quality is assessed by an operator.

  2. Immediate assess of technique success rate

    Time frame: 2 days

    After performing RFA, patients were transferred CT unit to confirm immediate technique success. It is performed in both a) visual inspection using pre-and post-RFA images side-by-side comparison and b) software assisted inspection which register pre-and post-RFA scans. The results would be used to perform additional treatment (2nd look RFA).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Medical Research Collaborating Center
  • RF medical

Registry information

Official study title

Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Feb 5, 2016
Registry last updated
Mar 18, 2021

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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