Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies

Liver Malignant Tumors Clinical Trial

Official title:

Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426992
• Other study ID #: 2402-111-151
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: Hyun Hee Lee
• Phone: 82-2-2072-4177
• Email: redlion55[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Child-Pugh Class A or B
• Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered

Exclusion Criteria:

• In cases where there are three or more malignant liver tumors
• When the maximum size of the tumor exceeds 4 cm
• Diffuse infiltrative type of cancer with unclear tumor boundaries
• When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more
• Severe liver failure (Child-Pugh Class C)
• In cases of vascular invasion by malignant liver tumors
• Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%)
• In cases of multiple extrahepatic metastases
• Situations where it is highly unlikely to obtain appropriate data for research purposes

Related Conditions & MeSH terms

• Liver Malignant Tumors
• Liver Neoplasms

Intervention

Procedure:
• Microwave ablation
Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.	Immediately after ablation
Primary	Local tumor progression rate	Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success	12 months after ablation
Secondary	Complication after ablation	Post ablation complications were defined as problems noted within 1 month after MWA as well as additional complications identified on follow-up imaging and judged to be likely caused by ablation.	Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
Secondary	Recurrence-free survival	Recurrence-free survival was defined as the interval between ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.	12 months after ablation