The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
Age greater than 18 years.
Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
Patients with severe pulmonary fibrosis and pulmonary hypertension.
Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
Parallel
The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
DeviceProcedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
DeviceProcedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
Complete ablation rate at 6 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.
Technical success rate
It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.
Complete ablation rate 12 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
Local control rate at 1 year, 2 years and 3 years after ablation
It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation.
Progression free survival (PFS)
It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.
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Hangzhou Broncus Medical Co., Ltd.
Lead sponsor
Shanghai Chest Hospital
Collaborator
