Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules
Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules: All 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Technical success rate (at the lesion level) — 6 months 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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