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

NCT04331184 | Unknown

• 1 other identifier: H-1907-157-1050
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiofrequency Ablation; Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Local tumor progression

  12 months

Secondary Outcomes (5)

• Overall survival rate

  12 months

• Recurrence free survival

  12 months

• Procedure time

  immediately

• complication rate

  immediately

• technical success rate

  immediately

Study Arms (1)

RFA using combined bipolar and monopolar energy delivery

EXPERIMENTAL

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

Interventions

RFA using combined bipolar and monopolar energy deliver PROCEDURE

RFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization.

RFA using combined bipolar and monopolar energy delivery

Eligibility Criteria

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

You may qualify if:

• agree to the protocol's requirements and submit a consent form
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver 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

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: January 28, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)