Radiofrequency Ablation Using Combined RF Energy Delivery... | NCT06682377

Studies
Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma

NCT06682377

Sponsor

Seoul National University Hospital

Status

Active, not recruiting

Last Update Posted

Nov 12, 2024Actual

Enrollment

159Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

Radiofrequency ablation alone

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2021Actual

Primary Completion Date

Mar 29, 2024Actual

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Nov 2, 2024

First Submission Date that Met QC Criteria

Nov 7, 2024

First Posted Date

Nov 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2024

Last Update Posted Date

Nov 12, 2024Actual

Description Module

Brief Summary

The purpose of this study is to evaluate, through a prospective multicenter trial, the procedural time, safety, technical success rate for achieving a safety margin of at least 5 mm around the tumor, and the clinical efficacy (local and remote recurrence rates: estimated local recurrence rate at 12 months) of radiofrequency ablation using the "No-touch" technique. This approach employs Octopus electrodes and combined radiofrequency energy delivery (dual switching monopolar and bipolar mode) for the treatment of hepatocellular carcinoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

159Estimated

Label	Type	Description	Intervention Names
No touch RFA with dual switching monopolar + bipolar mode	Experimental		Procedure: Radiofrequency ablation alone

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency ablation alone	Procedure	No touch RFA with dual switching monopolar + bipolar mode	No touch RFA with dual switching monopolar + bipolar mode

Measure	Description	Time Frame
Estimated local tumor progression rate		12 months after procedure

Eligibility Module

Eligibility Criteria

**Inclusion Criteria**

Agreement to the protocol requirements and provision of informed consent.
Age between 20 and 85 years.
Child-Pugh Class A or B7.
Patients with liver cirrhosis who are candidates for radiofrequency ablation (RFA) based on multi-detector computed tomography (MDCT) or multi-detector computed tomography (MRI) within 60 days, with a suspected hepatocellular carcinoma (HCC) lesion of 1-3 cm.
- **HCC Diagnostic Criteria:** A. Presence of risk factors (e.g., hepatitis B virus (HBV) positive, hepatitis C virus (HCV) positive, liver cirrhosis).
B. Findings consistent with HCC on at least one imaging modality (MDCT, dynamic MRI, or Primovist MRI) according to the Korean Liver Cancer Association (KLCA) criteria.

C. Histological diagnosis of HCC.
No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.

**Exclusion Criteria**

Presence of three or more malignant liver tumors.
Diffuse infiltrative type tumors with unclear boundaries.
Recurrent HCC within two years of previous treatment.
Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
Vascular invasion by malignant liver tumors.
Severe coagulopathy (platelets <50,000/mm³ or International Normalized Ratio (INR) >50% prolongation).
Presence of extrahepatic metastasis.
Situations where obtaining appropriate data for the study is unlikely.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative