Robotic-Assisted Bronchoscopy-Guided Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules

A Feasibility Study on Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules Under Robotic-Assisted Bronchoscopy: A Prospective, Single-Arm, Open-Label Clinical Study：ROBUST Study

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.

Inclusion Criteria:

• 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);
• Multidisciplinary evaluation shows that the patient cannot tolerate surgery and radiotherapy, or the patient refuses surgery and radiotherapy after full informed consent;
• The patient understands and agrees to receive synchronous biopsy and ablation treatment under robotic-assisted bronchoscopy and signs a written informed consent form.

Exclusion Criteria:

• 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;
• Anticoagulant or anti-platelet drugs have not been discontinued for the required time before surgery;
• Implanted cardiac pacemaker, defibrillator, or other electronic implants;
• Presence of important blood vessels that cannot be avoided along the biopsy path;
• Other conditions that the investigators consider not suitable for the patient to participate in this study.