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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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 |
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