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NCT Number: NCT02675881

Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.

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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

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
  • histologically confirmed HCC
  • histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
  • equal to or larger than 2cm, equal to or smaller than 5cm
  • available cross-sectional liver imaging within 30 days before RFA
  • signed informed consent

Exclusion criteria

  • history of local treatment on the index tumor
  • more than three tumors in a patient
  • tumors in central portion of portal vein or hepatic vein
  • Child-Pugh class C
  • vascular invasion by tumors
  • uncorrected coagulopathy
  • presence of multiple extrahepatic metastases

Treatment and study plan

DSM

Device

Monopolar RFA using dual switching mode (DSM)

separable clustered electrode

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(R)

Primary outcomes

  1. local tumor progression (LTP)

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 1 months

  2. rate of intrahepatic distant recurrence (IDR) after RFA

    Time frame: 12 months

  3. rate of extrahepatic metastasis (EM) after RFA

    Time frame: 12 months

Other outcomes

  1. Number of complication of RFA

    Time frame: 6 months

    incidence of any possible complication related with RFA

  2. Maximal diameter of ablative zone

    Time frame: 7 day

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

  3. ablation time

    Time frame: 1 day

    ablation time in a patient

  4. Real time US fusion image feasibility

    Time frame: 1 day after RFA procedure

    success or failure of accurate fusion between US and pre-RFA cross sectional images

  5. Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration.

    Time frame: 12 months

    Prediction of LTP by classifying patients according to assessing ablative margin in each method on a four point scale (1: residual tumor, 4: ablative margin equal to or larger than 5mm)

  6. Volume of ablative zone

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
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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