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To verify the clinical effectiveness and safety of the airway tree navigation system constructed by artificial intelligence (AI) in the navigation diagnosis of peripheral pulmonary nodules (PPLs).
Early diagnosis and treatment of lung cancer is of great significance, in which navigated tracheoscopic biopsy is an important tool for confirming the diagnosis of early lung cancer. Conventional navigation software realizes airway reconstruction and guides biopsy by recognizing differences in HU values on computed tomography scans. It is difficult for conventional navigation software to recognize the reconstruction due to the special characteristics of small airways that are susceptible to interference and collapse. Therefore, an AI deep learning approach can realize accurate construction of small airways and guide accurate biopsy. This study intends to validate the clinical effectiveness and safety of the AI-constructed airway tree navigation system in the navigational diagnosis of peripheral pulmonary nodules (PPLs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New navigation system group | Experimental | The new AI-constructed airway tree navigation system (SARS-pro) was used for preoperative navigation path planning. The SARS-pro navigation system was independently developed by the research group based on a conventional augmented reality optical navigation system (LungPro; Bronchus Company). |
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| Old navigation system group | Active Comparator | Preoperative navigation path planning was performed using the old VBN system (LungPro; Bronchus Company). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative navigation path planning using the SARS-pro navigation system | Diagnostic Test | The SARS-pro navigation system was used for preoperative navigation path planning for tracheoscopic biopsies in the new navigation system group (patients with suspected lung cancer). |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic positive yield | After biopsy by navigational bronchoscopy, the biopsy tissue was tested for lung cancer pathology. A positive diagnosis was defined when the pathology report was a neoplastic lesion (benign or malignant tumor). A positive diagnosis was also made if the pathology report was a granulomatous lesion (with tuberculosis or fungus). If the pathology was reported as an inflammatory cell infiltration or other non-specific inflammation in the lungs, the subject underwent another pathology biopsy after at least 3 months of follow-up to rule out false-positive results due to a change in the site of the lesion. | One month after the patients were enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Patients underwent a follow-up period of 3 days after navigational tracheoscopic biopsy, and subjects were followed for adverse events such as hemoptysis, pneumothorax, and mediastinal emphysema. | 3 days after navigational tracheoscopic biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enguo Chen, MD | Sir Run Run Shaw Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 6, 2024 | May 29, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Preoperative navigation path planning using the VBN navigation system | Diagnostic Test | The VBN navigation system was used for preoperative navigation path planning for tracheoscopic biopsies in the old navigation system group (patients with suspected lung cancer). |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |