Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Radiofrequency ablation

• Registration Number: NCT05580224
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-04
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 87

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with hepatocellular carcinoma (equal or less than 3 cm)	Radiofrequency ablation	Under the guidance of multimodality-ultrasound (US) fusion image, one of the three electrodes was placed across the portal vein branch near the tumor, and the other two electrodes were placed around the tumor through the previously planned approach path. After placement of electrodes, the temperature is maintained at 90-100 degrees Celsius for about 6-30 minutes depending on the size of the tumor, using the combined energy transfer mode that sequentially adds the bipolar mode and/or the monopolar mode.

Primary Outcome Measures

Name	Time	Method
Technical success	Immediately after radiofrequency ablation	Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Local tumor progression rate	12 months after radiofrequency ablation	Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success.

Secondary Outcome Measures

Name	Time	Method
Complication after radiofrequency ablation	Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months 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.
Recurrence-free survival	12 months after radiofrequency ablation	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of