Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Radiofrequency ablation

• Study Type: Interventional
• Enrollment (Anticipated): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with hepatocellular carcinoma (equal or less than 3 cm); 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 2208-187-1355

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No