The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Microwave ablation of lung tumors
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGComplete ablation rate of main lesion at 6 months post-procedure
6 months after ablation surgery, the proportion of patients with the main lesion maintained complete ablation among all evaluable patients who received transbronchial microwave ablation treatment.
Time frame: 6 months
Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions)
This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months and 12 months after transbronchial MWA.
Time frame: 12 months
Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients)
This refers to the proportion of patients with all treated lesions completely ablated in all patients who received transbronchial MWA at 6 months and 12 months after transbronchial MWA.
Time frame: 12 months
Progression-free survival rate at 12 months post-procedure
The proportion of patients who are progression-free (without disease progression or death from any cause) at 12 months post-procedure in the total evaluable patients who received transbronchial MWA.
Time frame: 12 months
Overall survival rate at 12 months post-procedure
The proportion of subjects who remain alive from the start of treatment until 1 year post-treatment.
Time frame: 12 months
Local progression-free survival rate at 6,12 months post-procedure
The proportion of subjects who remain local progression-free from the start of treatment until 6,12 months post-treatment.
Time frame: 12 months
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Technical success rate
It is defined as the proportion of ablation treatment surgeries where the ablation instrument is successfully placed in the target lesion and the ablation instrument is successfully removed after the completion of the treatment procedure among all ablation treatment surgeries.
Time frame: immediately after transbronchial MWA
Safety evaluation of medical device use
Evaluate whether the microwave therapy device's microwave output is normal and whether the cooling circulation system is normal. Evaluate whether the water flow of the disposable microwave ablation electrode is smooth, whether the rod temperature is normal, whether there is tissue adhesion during ablation, and whether there is coolant leakage.
Time frame: immediately after transbronchial MWA
ECOG Score
The Eastern Cooperative Oncology Group (ECOG) scoring criteria were used to evaluate the physical performance status of subjects during the screening period, 7 days after treatment or before discharge, 1 month after treatment, 3 months after treatment, 6 months after treatment, and 12 months after treatment. A decrease in the score ≥1 before and after was defined as an improvement in performance status, an increase of ≥1 point was defined as a decrease in performance status, and no change in the score was stable.
Time frame: 12 months