Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies
NCT ID: NCT06426992
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2024-04-30
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with malignant liver tumors
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.
Microwave 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.
Interventions
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Microwave 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
85 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jeong Min Lee
Professor
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2402-111-151
Identifier Type: -
Identifier Source: org_study_id
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