Microwave ablation for small liver tumors
Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study
This study tests if a new microwave treatment can safely remove small liver tumors and reduce the chances of them coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06426992 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of microwave ablation using the Starwave Microwave Generator for treating small liver malignancies. It aims to achieve a safety margin of at least 5 mm around the tumor during the procedure and assesses the local recurrence rate after one year through follow-up imaging. Patients with hepatocellular carcinoma or metastatic liver cancer measuring 4 cm or less are eligible for this intervention. The study focuses on determining the technical success rate of this minimally invasive treatment approach.
Who should consider this trial
Good fit: Ideal candidates include patients with Child-Pugh Class A or B liver function and small liver tumors of 4 cm or less.
Not a fit: Patients with multiple malignant tumors, larger tumors, or severe liver failure are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with small liver tumors, potentially reducing recurrence rates.
How similar studies have performed: Other studies have shown promising results with microwave ablation for liver tumors, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hyun Hee Lee
- Email: redlion55@naver.com
- Phone: 82-2-2072-4177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.