The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
Age ≥18 years.
Pathologically confirmed non-small cell lung cancer, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3; or metastatic lung tumors with the primary lesion well controlled, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3.
Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
Determined to be unsuitable for or unwilling to undergo surgery and radiotherapy.
Unable to tolerate or unwilling to undergo general anesthesia.
Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy.
Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure.
Evidence of intrathoracic lymph node metastases or extrathoracic metastases within 1 month before the procedure, except for extrathoracic metastases that had been effectively controlled by local treatment.
Single group
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation
Procedure/SurgeryAll procedures will be performed under general anesthesia with endotracheal intubation. The operator will remotely manipulate the control console to navigate the robotic bronchoscope to the target bronchus. For lesions with no ideal bronchial access, a tunnel to the target lesion will be established by needle puncture. Radial endobronchial ultrasound (rEBUS) may be selectively used to identify and confirm the lesion location. The cryoablation probe will be advanced into the lesion through the bronchus or the established tunnel. After confirming the position of the cryoablation probe using cone-beam computed tomography (CBCT), cryoablation will be performed. Immediately after cryoablation, CBCT will be performed to evaluate the spatial relationship between the ablation zone and the target lesion. An imaging safety margin extending at least 5 mm beyond the margin of the target lesion will serve as an important criterion for technical success.
Technical Success Rate (Lesion Level)
The proportion of lesions achieving effective ablation under 5G-enabled remote robotic-assisted bronchoscopy guidance among all lesions that undergo ablation. Effective ablation is defined as an immediate post-procedural imaging finding demonstrating an ablation zone extending at least 5 mm beyond the margin of the target lesion.
Complete Ablation Rate at 6 Months (Lesion Level)
The proportion of lesions that maintain complete ablation at 6 months after transbronchial cryoablation among all lesions that undergo ablation.
Complete Ablation Rate at 12 Months (Lesion Level)
The proportion of lesions that maintain complete ablation at 12 months after transbronchial cryoablation among all lesions that undergo ablation.
Intrapulmonary Progression-Free Survival Rate at 6 Months (Patient Level)
The proportion of patients without intrapulmonary disease progression at 6 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.
Intrapulmonary Progression-Free Survival Rate at 12 Months (Patient Level)
The proportion of patients without intrapulmonary disease progression at 12 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.
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