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Trial Title:
Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies
NCT ID:
NCT06426992
Condition:
Liver Malignant Tumors
Conditions: Official terms:
Liver Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Microwave ablation
Description:
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.
Arm group label:
Patients with malignant liver tumors
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyun Hee Lee
Phone:
82-2-2072-4177
Email:
redlion55@naver.com
Investigator:
Last name:
Jeong Min Lee, MD, PhD
Email:
Principal Investigator
Start date:
April 30, 2024
Completion date:
March 30, 2026
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06426992
