Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Anatomical Radiofrequency Ablation for Peripherally Located Small Hepatocellular Carcinoma Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580224
• Other study ID #: 2208-187-1355
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: Hyun Hee Lee
• Phone: 82-2-2072-4177
• Email: redlion55[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Child-Pugh class A or B7.

• Presence of chronic hepatitis B or liver cirrhosis.

• Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.

• Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.

• Tumor location is less than 5 cm from liver capsule.

Exclusion Criteria:

• The number of tumor is three or more.

• Tumor size is over 3 cm.

• Tumor location is over 5 cm from liver capsule.

• Child-Pugh class B8-9 or C.

• Presence of macrovascular invasion and/or distant metastasis.

• Platelet count < 50,000 mm3, or international normalized ratio > 1.5 (prothrombin time >1.5 × normal).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Radiofrequency ablation
Radiofrequency ablation is performed for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes. One of three electrodes is placed across the 4th or 5th portal vein branches near the target tumor which enables anatomical ablation of tumor.

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
Primary	Technical success	Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.	Immediately after radiofrequency ablation
Primary	Local tumor progression rate	Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success.	12 months after radiofrequency ablation
Secondary	Complication after radiofrequency ablation	Post-radiofrequency ablation complications were defined as problems noted within 1 month after RFA as well as additional complications identified on follow-up imaging and judged to be likely caused by radiofrequency ablation.	Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
Secondary	Recurrence-free survival	Recurrence-free survival was defined as the interval between radiofrequency ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.	12 months after radiofrequency ablation