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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832882
• Other study ID #: SNUH-2016-2244
• Status: Completed
• Phase: N/A
• Start date: October 21, 2016
• Est. completion date: January 17, 2020

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 17, 2020
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ablation time	ablation time for tumor ablation	3 days after RFA
Other	Intrahepatic distant mets	incidence of intrahepatic distant metastasis after RFA	12 months after RFA
Other	Extrahepatic distant mets	incidence of extrahepatic distant metastasis after RFA	12 months after RFA
Other	Technical efficacy 1	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	2 days after RFA
Other	Technical efficacy 2	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	2 days after RFA
Primary	12 month local tumor progression (LTP) rate		12 month after RFA
Secondary	tumor seeding rate	incidence of tract seeding after RFA.	12 months after RFA
Secondary	Complication rate related with RFA	RFA-related complication rate such as death, abscess, bleeding..etc.	1 month
Secondary	Technical success rate	presence or absence of residual lesion on follow-up imaging	1 months