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

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

Recruiting
20-85 years
All
Phase N/A

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Overview

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

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

Study details
    Liver Malignant Tumors

NCT06426992

Seoul National University Hospital

27 May 2024

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