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RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode

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ClinicalTrials.gov Identifier: NCT02806076
Recruitment Status : Unknown
Verified July 2016 by Jeong Min Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

Brief Summary:
The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Procedure: No-touch RFA arm Procedure: Conventional tumor puncture RFA arm Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: No-touch RFA arm
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
Procedure: No-touch RFA arm
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Active Comparator: Conventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.
Procedure: Conventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.




Primary Outcome Measures :
  1. 12 month local tumor progression (LTP) rate [ Time Frame: 12 months after RFA ]

Secondary Outcome Measures :
  1. 2. tumor seeding rate [ Time Frame: 12 months after RFA ]
  2. Complication rate related with RFA [ Time Frame: 1 month after RFA ]
    RFA-related complication rate such as death, abscess, bleeding..etc.

  3. Technical success rate [ Time Frame: 1 month after RFA ]
    presence or absence of residual lesion on follow-up imaging


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child-Pugh class A
  • patient with 1-2.5cm sized HCC
  • 1 or 2 HCC lesions

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)

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): NCT02806076


Contacts
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Contact: Hyun Hee Lee, RN 82-2-2072-4177 redlion55@naver.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Jeong Min Lee, MD, PhD         
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: NCT02806076    
Other Study ID Numbers: SNUH-2016-2243
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
HCC
RFA
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases