Novel Thin Bronchoscope Versus Ultrathin Bronchoscope for the Diagnosis of Peripheral Pulmonary Nodules
- Conditions
- Lung Cancer (Diagnosis)
- Registration Number
- NCT07135297
- Lead Sponsor
- Shanghai Chest Hospital
- Brief Summary
This is a prospective, randomised, non-inferior, multicenter study in consecutive patients with solid or sub-solid PPLs 8 to 30 mm in diameter.The subjects will be randomly assigned in a 1:1:1 ratio to the 3.0mm outer diameter/1.7mm forceps channel ultrathin bronchoscope group (UTB-VBN-EBUS group), the 3.3mm outer diameter/2.0mm forceps channel novel thin bronchoscope combined with guide sheath group (TB1-VBN-EBUS-GS group), and the 4.2mm outer diameter/2.8mm forceps channel novel thin bronchoscope combined with guide sheath group (TB2-VBN-EBUS-GS group). All procedures will be performed using UTB or TB with the guidance of virtual bronchoscopic navigation (VBN) combined with radial endobronchial ultrasound (rEBUS), but without fluoroscopy. A small forceps will be used in UTB-VBN-EBUS group and TB1-VBN-EBUS-GS group, while a standard forceps will be used in TB2-VBN-EBUS-GS group. Primary endpoint is the diagnostic yield.
- Detailed Description
This is a prospective, randomised, non-inferior, multicenter study. The inclusion criteria are patients whose chest imaging shows suspiciously malignant peripheral lung nodules (the nodules are surrounded by lung tissue and are located below the segmental bronchus), and the diameter of the lesion is between 8mm and 30mm. The subjects will be randomly assigned in a 1:1:1 ratio to the 3.0mm outer diameter/1.7mm forceps channel ultrathin bronchoscope group (UTB-VBN-EBUS group), the 3.3mm outer diameter/2.0mm forceps channel novel thin bronchoscope combined with guide sheath group (TB1-VBN-EBUS-GS group), and the 4.2mm outer diameter/2.8mm forceps channel novel thin bronchoscope combined with guide sheath group (TB2-VBN-EBUS-GS group). All procedures were performed using UTB or TB with the guidance of virtual bronchoscopic navigation (VBN) combined with radial endobronchial ultrasound (rEBUS), but without fluoroscopy. A small forceps was used in UTB-VBN-EBUS group and TB1-VBN-EBUS-GS group, while a standard forceps was used in TB2-VBN-EBUS-GS group. Primary endpoint is the diagnostic yield. The secondary endpoints include total examination time, the time from bronchoscope insertion of the glottis to the time of removing from the glottis; duration time of finding lesions, the time from insertion of ultrasound probe to withdrawal of ultrasound probe when a rEBUS view was seen; the proportion of lesions visible by rEBUS; factors affecting the diagnostic yield, difference in the bronchus level reached with the bronchoscope; difference in diagnostic yield; and complication rate. Complication rate includes adverse events related to the procedure during or within 1 month after the operation.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 465
- Patients older than 18 years old.
- Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) that need to be confirmed by pathology. The length diameter of the lesion is no less than 8 mm and no more than 30mm.
- Patients without contraindications of bronchoscopy.
- Patients have good medical adherence and signed informed consent.
- Peripheral pulmonary lesion is pure ground-glass opacity.
- Visible lumen lesions in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus).
- The target lesion has been treated.
- Diffuse pulmonary lesions.
- The investigators believe that patient has other conditions that are not suitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Diagnostic yield up to 6 months Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary nodules
- Secondary Outcome Measures
Name Time Method Total examination time During the procedure Total examination time is defined from the time that the bronchoscope is inserted beyond the glottis, until the bronchoscope has been removed from the glottis after examination
Duration of finding lesions During the procedure Duration of finding lesions defined from insertion of ultrasound probe to withdrawal of ultrasound probe
Factors affecting the diagnosis yield Up to 6 months The factors affecting the diagnostic yield includes the nodules nature, size, location, the position of the ultrasound probe relative to the lesions etc.
Difference in the bronchus level reached with the bronchoscope During the procedure Level: Bronchus is level 0, leaf bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3
Difference in diagnostic yield between the two novel thin bronchoscopes groups Up to 6 months Difference in diagnostic yield between the two novel thin bronchoscopes with guide sheath combined small biopsy forceps and conventional biopsy forceps.
Complication rate 1 month The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation.
Trial Locations
- Locations (5)
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
Shanghai Chest Hospital
🇨🇳Shanghai, China
Peking University First Hospital🇨🇳Beijing, Beijing, China