"No-Touch" Radiofrequency Ablation for Small Hepatocellular Carcinoma (≤ 3cm): A Prospective Multicenter Study

NCT04803890 | Terminated

• 1 other identifier: H-2003-068-1108
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective multicenter study of the duration of treatment, the success rate, the frequency of complications, and the local recurrence rate of 12 months when Radio-frequency ablation therapy is performed for the treatment of HCC using the 'No touch' technique as a combined high-frequency transmission mode with Octopus electrodes. It aims to evaluate through. In addition, the results obtained from this prospective study were as follows: 1) Patients who underwent Radio-frequency ablation therapy by puncturing an existing tumor, and 2) Patients who underwent microwave ablation during the study period. The secondary goal is to evaluate which method is more effective in reducing the treatment time and recurrence rate compared to.

Conditions

Radiofrequency Ablation; Microwave Ablation

Outcome Measures

Primary Outcomes (1)

• Local tumor progression (LTP) rate

  No. of participants with LTP/ No. of participants receiving RFA

  12 months after RFA

Secondary Outcomes (2)

• Intrahepatic distant recurrence (IDR) rate

  12 months after RFA

• Complication rate

  12 months after RFA

Study Arms (1)

No touch radiofrequency ablation

EXPERIMENTAL

A total of 150 patients who have decided to participate in the study will be included, and prospective study will be performed to these patients for radio-frequency ablation using octopus electrodes, combined high-frequency transmission mode, and the 'No touch' technique.

Procedure: "No-Touch" Radiofrequency Ablation

Interventions

"No-Touch" Radiofrequency Ablation PROCEDURE

"No-Touch" Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode

No touch radiofrequency ablation

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 or B7
• Among patients with cirrhosis, patients with hepatocellular carcinoma having a size of 1 cm-3 cm suspected of MDCT or MRI performed within 60 days are considered for radio-frequency ablation
• Patients who do not have a history of treatment for previous hepatocellular carcinoma, or who have a history of treatment for previous hepatocellular carcinoma, if recurrence has not been confirmed for at least 2 years after treatment

You may not qualify if:

• the number of liver tumors is 3 or more
• the maximum size of the tumor exceeds 3 cm
• diffuse infiltrative type
• the tumor adheres to the portal vein or hepatic vein or biliary tract of 5 mm or more
• patients with previous medical history of hepatocellular cancer who have recurrent hepatocellular cancer within 2 years
• the tumor is not visible even under CEUS-fusion image guidance
• Child-Pugh class B8 or C
• in case of invasion of liver vessels due to malignant hepatocellular carcinoma
• severe coagulopathy
• multiple distant metastasis
• the situation where the probability of obtaining appropriate data suitable for the research purpose is very low

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samsung Medical Center: collaborator
• Chosun University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: March 18, 2021
• Study Start: April 1, 2019
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)