This is a prospective, single-arm, open-label clinical study. The primary study objective is to evaluate the feasibility of synchronous biopsy and radiofrequency ablation for pulmonary nodules under robotic-assisted bronchoscopy.
Age ≥ 18 years old;
Chest CT indicates pulmonary nodules, highly suspected of being malignant;
Size of pulmonary nodules: 8 mm < maximum diameter ≤ 30 mm, and the number of pulmonary nodules requiring intervention ≤ 3;
Preoperative imaging evaluation indicates no clear lymph node metastasis or distant metastasis (cT1N0M0);
Patients who cannot tolerate general anesthesia due to advanced age or severe cardiopulmonary diseases, or other reasons;
The target nodule has been diagnosed as a malignant tumor or metastasis;
Patients with severe bleeding tendency or uncorrectable coagulation disorder (platelet count < 50×10^9 /L, prothrombin time > 18s, prothrombin activity < 40%);
Severe pulmonary fibrosis and pulmonary hypertension;
Single group
Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules
Procedure/SurgeryAll procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. All procedures are performed under the guidance of shape-sensing robotic-assisted bronchoscopy integrated with mobile cone-beam computed tomography. Cyobiopsy is performed first using the 1.1-mm cryoprobe, followed by intraoperative frozen section for rapid diagnosis. If malignancy is confirmed, radiofrequency ablation is conducted in the same procedure.
Technical success rate (at the lesion level)
The proportion of lesions with a definite malignant diagnosis by synchronous biopsy and effective ablation (with postoperative immediate imaging indicating that the ablation range is at least 5 mm larger than the boundary of the target lesion) among the lesions ultimately diagnosed as malignant.
Biopsy diagnostic yield (at the lesion level)
The proportion of lesions with a definite malignant or specific benign diagnosis by biopsy among all the lesions undergoing biopsy, evaluated by the pathological diagnosis.
Sensitivity of malignancy (at the lesion level)
The proportion of lesions with a definite malignant diagnosis by biopsy among all the lesions confirmed to be malignant by the gold standard of pathology, evaluated by the pathological diagnosis.
Complete ablation rate (at the lesion level)
The proportion of completely ablated lesions after ablation treatment among all the lesions undergoing ablation treatment, evaluated at 3 months, 1 year, 2 years, 3 years, and 5 years, respectively.
Local progression-free period (at the lesion level)
The time from when the patient receives treatment until the target lesion shows local progression.
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