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

Carcinoma, Hepatocellular Clinical Trial

Official title:

Radiofrequency Ablation Using Dual Cooled-Wet Electrode for Small Hepatocellular Carcinoma With No-touch Technique: Preliminary Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02806076
• Other study ID #: SNUH-2016-2243
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: Hyun Hee Lee, RN
• Phone: 82-2-2072-4177
• Email: redlion55[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

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 months after RFA
Secondary	2. tumor seeding rate		12 months after RFA
Secondary	Complication rate related with RFA	RFA-related complication rate such as death, abscess, bleeding..etc.	1 month after RFA
Secondary	Technical success rate	presence or absence of residual lesion on follow-up imaging	1 month after RFA