RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes

NCT04471272 | Unknown

• 1 other identifier: H-1909-086-1064
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators intend to perform RFA therapy on HCC less than 4 cm in size using octopus electrode, double alternating unipolar high-frequency transmission mode and gradual high-frequency energy loading mode, and to find out the therapeutic results. The primary evaluation variable is the ideal technical success rate for securing a safety margin of 5 mm or more around the tumor on the CT obtained immediately after the procedure, and the secondary evaluation variable is the volume of the cauterization lesion per unit time measured on the CT obtained immediately after the procedure, The local tumor recurrence rate, survival rate and disease-free survival rate of 12 months after the procedure, the presence or absence of multiple recurrences within the same segment, the actual procedure time, and the incidence of complications associated with the procedure are examined. The performance of RFA therapy of HCC using the Octopus electrode and gradual high-frequency energy transfer mode is compared with that of the existing Octopus electrode and RFA therapy using the basic maximum high-frequency energy transfer mode using historic cohort.

Conditions

Radiofrequency Ablation; Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Ideal technical success rate

  Secure a safety margin of 5 mm or more around the tumor on CT obtained immediately after the procedure

  Time: immediately

Secondary Outcomes (6)

• Ablation volume

  Time: immediately

• Local recurrence rate

  Time: 12months

• Overall survival rate

  Time: 3years

• Disease free survival

  Time: 3years

• Complication rate

  Time: immediately

Study Arms (1)

RFA using gradual RF energy delivery mode

EXPERIMENTAL

RFA therapy is performed on HCC less than 4 cm in size using an octopus electrode, a double-shift unipolar high-frequency transmission mode, and a gradual high-frequency energy loading mode.

Procedure: RFA using gradual RF energy delivery mode with Octopus electrodes

Interventions

RFA using gradual RF energy delivery mode with Octopus electrodes PROCEDURE

RFA therapy is performed on HCC less than 4 cm in size using an octopus electrode, a double-shift unipolar high-frequency transmission mode, and a gradual high-frequency energy loading mode.

RFA using gradual RF energy delivery mode

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
• among patients with chronic hepatitis or cirrhosis, MDCT or MRI hepatocellular carcinoma of less than 4 cm in size was suspected, and was referred to the radiology department considering clinical RFA therapy as a clinical judgment.

You may not qualify if:

• when the number of malignant HCC is 3 or more
• if the tumor has a maximum size of more than 4 cm
• diffuse infiltrative HCC
• Child-Pugh class B or C
• If there is an invasion of liver vessels due to malignant HCC
• 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

Central Study Contacts

Jeong Min Lee, MD, PhD

CONTACT

+82-2072-3107; jmlshy2000@gmail.com

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: * Study population: RFA using gradual RF energy delivery mode with Octopus electrodes * Control group: Over a period of two years from 2017 to 2018, the patients who performed RFA for HCC using octopus electrodes and the maximum high-frequency energy transfer mode technique were collected. After performing propensity score matching analysis using variables of liver function values, the same number of controls are selected and set.

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: July 15, 2020
• Study Start: January 6, 2020
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2023
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)