Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.
The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Complete tumor ablation rate
the percentage of complete ablation subjects for all subjects undergoing ablation surgery. Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation.
Time frame: 1 month after surgery
First complete tumor ablation rate
the percentage of subjects who did not undergo the second one month after the operation accounted for all the ablation trials.
Time frame: 1 month after surgery
Complete ablation rate of lesions
the percentage of lesions that are completely ablated to all lesions undergoing ablation.
Time frame: 1 month after surgery
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Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Shandong Provincial Hospital
Jinan, Shandong, China
Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
...and 3 more locations