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

RECRUITINGN/ASponsored by Seoul National University Hospital
Actively Recruiting
PhaseN/A
SponsorSeoul National University Hospital
Started2024-04-30
Est. completion2026-03-30
Eligibility
Age20 Years – 85 Years
Healthy vol.Accepted

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

Age: 20 Years – 85 YearsHealthy volunteers accepted
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

Conditions4

CancerLiver CancerLiver DiseaseLiver Malignant Tumors

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