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RFA Using Dual Cooled-wet Electrode for Treatment of Recurrent HCC After Locoregional Treatment

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ClinicalTrials.gov Identifier: NCT03806218
Recruitment Status : Active, not recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: Bipolar RFA Device: SM-RFA Device: Dual internally cooled-wet electrodes Device: Separable clustered electrodes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation Using Dual Cooled-wet Electrode for Treatment of Recurrent HCC After Locoregional Treatment: A Preliminary Randomized Controlled Study
Actual Study Start Date : May 16, 2015
Actual Primary Completion Date : May 16, 2018
Estimated Study Completion Date : February 12, 2019

Arm Intervention/treatment
Active Comparator: DCW-RFA
Bipolar RFA using dual internally cooled-wet electrodes
Device: Bipolar RFA
Bipolar RFA in which RF currents flow between two electrodes

Device: Dual internally cooled-wet electrodes
Saline-enhanced dual internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity

Active Comparator: SM-RFA
Switching monopolar RFA using separable clustered electrodes
Device: SM-RFA
Monopolar RFA using multiple electrodes with switching mode

Device: Separable clustered electrodes
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 Name: Octopus®




Primary Outcome Measures :
  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 Outcome Measures :
  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 after RFA ]
    Cumulative intrahepatic distant recurrence (IDR) rate over one year after RFA

  3. EM rate [ Time Frame: 12 months after RFA ]
    Cumulative extrahepatic metastasis (EM) rate over one year after RFA

  4. Local tumor progression (LTP) [ Time Frame: 12 months after RFA ]
    Cumulative LTP rates in two groups in a year after RFA


Other Outcome Measures:
  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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 %)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806218


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital

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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03806218     History of Changes
Other Study ID Numbers: SNUH-2015-0401
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeong Min Lee, Seoul National University Hospital:
RFA

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases