RFA for Small HCC With No-touch Technique Using Octopus Electrode
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|ClinicalTrials.gov Identifier: NCT02832882|
Recruitment Status : Unknown
Verified July 2016 by Jeong Min Lee, Seoul National University Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Procedure: No-touch RFA Procedure: Conventional tumor puncture RFA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Experimental: No-touch RFA arm
No-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique.
Procedure: No-touch RFA
No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.
Active Comparator: Conventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique.
Procedure: Conventional tumor puncture RFA
Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.
- 12 month local tumor progression (LTP) rate [ Time Frame: 12 month after RFA ]
- tumor seeding rate [ Time Frame: 12 months after RFA ]incidence of tract seeding after RFA.
- Complication rate related with RFA [ Time Frame: 1 month ]RFA-related complication rate such as death, abscess, bleeding..etc.
- Technical success rate [ Time Frame: 1 months ]presence or absence of residual lesion on follow-up imaging
- Ablation time [ Time Frame: 3 days after RFA ]ablation time for tumor ablation
- Intrahepatic distant mets [ Time Frame: 12 months after RFA ]incidence of intrahepatic distant metastasis after RFA
- Extrahepatic distant mets [ Time Frame: 12 months after RFA ]incidence of extrahepatic distant metastasis after RFA
- 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
- 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
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): NCT02832882
|Contact: Hyun Hee Lee, RNemail@example.com|
|Principal Investigator:||Jeong Min Lee, MD||Seoul National University Hospital|