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

Official title

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

Overview

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.

Interventions

• Procedure 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.

Primary outcome measures

• Technical success rate (at the lesion level) [Time frame: 6 months]

Secondary outcome measures (8)

• Biopsy diagnostic yield (at the lesion level) [Time frame: 6 months]
• Sensitivity of malignancy (at the lesion level) [Time frame: 6 months]
• Complete ablation rate (at the lesion level) [Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Local progression-free period (at the lesion level) [Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Progression-free survival [Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Overall survival [Time frame: 3 months, 1 year, 2 years, 3 years, and 5 years]
• Pulmonary function indicators (at the patient level) [Time frame: 1 year]
• The incidence of procedure-related complications (at the patient level) [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT07545057 · IS26059

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗