Enhanced Radiofrequency Ablation for Recurrent HCC Post-TACE Using Twin Internally Cooled-Perfusion Electrodes

NCT07192172 | Completed DMC

• 2 other identifiers: SNUH 1611124811No. 06-2017-0260
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective study evaluates the therapeutic outcomes of saline-augmented bipolar radiofrequency ablation (RFA) with twin internally cooled-perfusion (TICP) electrodes for treating recurrent hepatocellular carcinoma (HCC) following trans-arterial chemoembolization (TACE).

Conditions

Hepatocellular Carcinoma; Liver Neoplasms

Keywords

Recurrent Hepatocellular carcinoma; Bipolar; HCC; Image guidance; Local tumor progression; ablation

Outcome Measures

Primary Outcomes (1)

• 2-year cumulative incidence of local tumor progression (LTP)

  2-year cumulative incidence of local tumor progression (LTP) Description: LTP defined as the appearance of enhancement at the ablation margin on contrast-enhanced imaging

  Time Frame: 2 years

Study Arms (1)

Experimental: Bipolar RFA using TICP electrodes

OTHER

All participants receive bipolar RFA treatment using TICP electrodesTreatment is conducted under real-time ultrasound-CT/MR fusion guidance

Device: Bipolar radiofrequency ablation using twin internally cooled perfusion electrodes

Interventions

Bipolar radiofrequency ablation using twin internally cooled perfusion electrodes DEVICE

Device: Twin Internally Cooled-Perfusion (TICP) Electrodes Two 17-gauge internally cooled-perfusion electrodes Multichannel RF generator (RF Medical Co., Seoul, Korea) Bipolar mode application Saline perfusion rate: approximately 1 cc/min

Experimental: Bipolar RFA using TICP electrodes

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20-85 years Child-Pugh Class A liver function Radiologically confirmed locally recurrent HCC following conventional TACE treatment Recurrent HCC defined as arterially enhancing tumor at the edge of treated tumor

You may not qualify if:

• More than three HCC nodules Tumors with ≥5 mm abutment length to main hepatic veins or first branches of main portal vein HCC nodules ≥3 cm Platelet count ≤50,000/mm³ or INR prolongation ≥50% Extrahepatic metastasis or vascular invasion Child-Pugh class B or C ECOG performance status ≥3 Poor acoustic window or inability to achieve percutaneous access

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hosptial

Seoul, Seoul, 03080, South Korea

Location

Related Publications (1)

• Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode. Korean J Radiol. 2021 Feb;22(2):179-188. doi: 10.3348/kjr.2020.0134. Epub 2020 Jul 22.

  PMID: 32729269 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment, radiofrequency ablation (NT-RFA) using twin cooled wet (TCW) electrodes in patients experiencing recurrent hepatocellular carcinoma

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: September 1, 2017
• Primary Completion: January 31, 2019
• Study Completion: December 1, 2020
• Last Updated: April 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication
• Access Criteria: Conditions for Use: for academic purposes only

Locations

KR (1)