RecruitingNot ApplicableNCT06426992

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

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

Sponsor

Seoul National University Hospital

Enrollment

62 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Malignant Tumors

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.

Eligibility

Min Age: 20 YearsMax Age: 85 Years

Inclusion Criteria2

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 Criteria9

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

Interventions

PROCEDUREMicrowave 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.