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Completed

NCT Number: NCT02832882

RFA for Small HCC With No-touch Technique Using Octopus Electrode

In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma 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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Child-Pugh class A
  • patient with 1cm-2.5cm sized HCC
  • 1 or 2 HCCs
  • being referred for curative purpose of RFA
  • sign informed consent

Exclusion criteria

  • maximum tumor diameter greater than 2.5cm
  • Child-Pugh class B or C
  • more than 3 HCC lesions
  • invisible tumor even after US/CT or US/MR fusion
  • presence of vascular tumor thrombosis or extrahepatic metastasis
  • severe coagulopathy (PLT < 50K, PT < 50% of normal range)

Treatment and study plan

No-touch RFA

Procedure

No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.

Conventional tumor puncture RFA

Procedure

Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.

Primary outcomes

  1. 12 month local tumor progression (LTP) rate

    Time frame: 12 month after RFA

Secondary outcomes

  1. tumor seeding rate

    Time frame: 12 months after RFA

    incidence of tract seeding after RFA.

  2. Complication rate related with RFA

    Time frame: 1 month

    RFA-related complication rate such as death, abscess, bleeding..etc.

  3. Technical success rate

    Time frame: 1 months

    presence or absence of residual lesion on follow-up imaging

Other outcomes

  1. Ablation time

    Time frame: 3 days after RFA

    ablation time for tumor ablation

  2. Intrahepatic distant mets

    Time frame: 12 months after RFA

    incidence of intrahepatic distant metastasis after RFA

  3. Extrahepatic distant mets

    Time frame: 12 months after RFA

    incidence of extrahepatic distant metastasis after RFA

  4. Technical efficacy 1

    Time frame: 2 days after RFA

    Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using visual assessment

  5. Technical efficacy 2

    Time frame: 2 days after RFA

    Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using registration software

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jul 14, 2016
Registry last updated
Mar 22, 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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