The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer.
Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture. In recent years, with the development of navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety, as well as its long-term efficacy. This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study, randomized in a 1:1 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study endpoints were success rate of technique implementation, complete ablation rate at 12 months post-procedure, local control rate at 1, 2 and 3 years post-procedure, progression-free survival, overall survival and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
ablation
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGComplete ablation rate at 6 months post-procedure
This refers to the number of lesions completely ablated 6 months after ablative treatment as a proportion of the total number of ablative treated lesions.
Time frame: Up to 6 months
Success rate of technique implementation
Defined as the number of lesions reached by the ablation needle and successfully treated by ablation as a proportion of the total number of lesions to be ablated, as assessed by imaging immediately after ablation.
Time frame: Immediate postoperative
Complete ablation rate at 12 months post-procedure
This refers to the number of lesions completely ablated 12 months after ablative treatment as a proportion of the total number of ablative treated lesions.
Time frame: Up to 12 months
Local control rate at 1, 2 and 3 years post-procedure
This refers to the number of completely ablated and incompletely ablated lesions at 1, 2 and 3 years after ablative treatment as a proportion of the total number of ablative treated lesions.
Time frame: Up to 36 months
Progression-free survival
Refers to the duration between the subject's study procedure and the first occurrence of disease progression or death from any cause, recorded through follow-up for up to 3 years.
Time frame: Up to 36 months
Overall survival
Refers to the duration between the subject's study procedure and the subject's death, recorded through follow-up for up to 3 years.
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety
Assessment of the incidence of device or procedure-related adverse events that occurred during the study.
Time frame: Up to 6 months