RFA Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes

Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study

In this study, a dual / Twin Cooled-wet electrode was used to perform RFA therapy on residual tumors after transarterial chemo-embolization and to find out the therapeutic results. The primary endpoint is the 12-month local recurrence rate, and the secondary endpoint is the survival rate, disease-free survival rate, actual procedure time, complications associated with the procedure, and the technical success rate for securing a safety margin of 3 mm or more around the tumor.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Hepatocellular; Radiofrequency Ablation
• Intervention / Treatment: Procedure: RFA using combined bipolar and monopolar energy deliver

Detailed Description

In the treatment of HCC, local interventional procedures such as transarterial chemo-embolization and RFA are one of the most widely used methods. The probability of complete necrosis is known to be about 50-60% and 80%, respectively, and in a few cases, viable tumors remain, requiring additional treatment. Thus, in the treatment of residual tumors after locoregional intervention, RFA therapy is known as a safe and effective treatment, and in practice, it can be said to be a treatment that is often performed for the treatment of residual viable tumors. Until now, single or alternating monopolar mode and bipolar mode or multi-bipolar mode have been used for the transfer of radio frequency energy. Unipolar mode is used most frequnetly. Currently, in the present application, an alternating monopolar mode using three electrodes (Octopus electrode) and a bipolar mode using two electrodes (Twin cooled wet electrod, RF Medical) have been mainly used. RFA therapy for residual tumors after locoregional intervention has theoretically some limitations. First, it is difficult to deliver a sufficient amount of the high-frequency electrode per hour due to the high electrical resistance of the tissue due to tissue necrosis, fibrosis, and distribution of non-homogeneous tissue after local intervention. Second, the high frequency energy is distributed non-uniformly in the tissue. One of the ways to overcome this is to generate a high heat in the center and periphery of the tumor to be treated, a method of uniformly transmitting a large amount of energy such as high frequency or microwave, or a strategy to improve the thermal conductivity and electrical conductivity. In order to do this, saline is delivered to the high-frequency electrode to improve electrical conductivity, and at the same time, high-frequency energy can be applied to the center of the tumor and the periphery of the tumor if high-frequency energy can be transferred between the electrodes or around the two electrodes installed in the tumor. It can be evenly delivered and the efficiency of heat transfer is improved, which will improve the therapeutic effect of high-frequency heat therapy on residual tumors after local intervention.

Recently, Rf Medical in Korea has developed a twin cooled wet (TCW) electrode capable of injecting physiological saline into these high frequency electrodes and has been approved for clinical use under medical insurance. About 30% has been used using a bipolar mode, which has a theoretical advantage to concentrate high-frequency energy between the electrode and the electrode. However, according to the experience in the present application, when the bipolar mode is used, the rate of ablation is very fast and the transmission of high-frequency energy is relatively easy in the center of the tumor, but the transmission of high-frequency energy in the periphery of the tumor is relatively low, resulting in about 30% of tumors. A marginal recurrence or residual tumor was experienced in the margin, and in the last 6 months, bipolar mode and switching monopolar mode were combined to prevent recurrence in the periphery of the tumor, and treatment was performed with the default setting. The result is low recurrence (6 months local recurrence rate of about 15%).

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: SAE JIN PARK, MD; Phone Number: 82220723107; Email: psjko05@gmail.com

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:

• agree to the protocol's requirements and submit a consent form
• 20 years old-85 years old
• Child-Pugh Class A and B
• Patients with residual HCC after locoregional treatment who meet the following conditions A. Patients with a single nodular HCC within 5 cm or multiple nodular HCC of 3 or less in all cases of focal cancer B. Patients who did not have vascular invasion or extrahepatic metastasis during locoregional intervention

Exclusion Criteria:

• When the number of malignant HCC is 3 or more
• If the tumor has a maximum size of 3 cm or more
• diffuse infiltrative HCC
• Child-Pugh class C
• If there is an invasion of liver vessels due to malignant liver tumors
• severe coagulopathy
• multiple distant metastasis
• situations where it is very unlikely to obtain appropriate data for research purposes

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: RFA using combined bipolar and monopolar energy delivery; Control group: The historic cohort is used to compare the results of the conventional alternating unipolar radiofrequency energy transfer mode with RFA.	Procedure: RFA using combined bipolar and monopolar energy deliver; RFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Local tumor progression	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival rate	Survival data	12 months
Recurrence free survival	Survival data	12 months
Procedure time	Procedure related outcome	immediately
complication rate	Procedure related outcome	immediately
technical success rate	Procedure related outcome	immediately

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

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: H-1907-157-1050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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