The study is designed to evaluate the safety and effectiveness of biopsy forceps combined with puncture biopsy for the diagnosis of peripheral pulmonary nodules under the guidance of Augmented Reality Navigation System combined with radial endobronchial ultrasound (r-EBUS), and to explore the factors influencing the diagnosis rate.
The study will last for no longer than 12 months. Patients will be first screened, and only after meeting all the inclusion criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive forceps biopsy combined with puncture biopsy to sample the target nodules. The primary endpoint is the combined diagnostic yield of forceps biopsy and puncture biopsy. The secondary endpoints include the success rate of biopsy, the operation time of the bronchoscope and so on.
Study Type
OBSERVATIONAL
Enrollment
50
During the operation, under the guidance of Augmented Reality Navigation, the bronchoscope will reach the location of the target pulmonary nodules, and the EBUS probe will be inserted through the bronchoscope working channel, and gradually approach the target nodules to obtain EBUS images. After typical EBUS images are observed and the location is confirmed, the EBUS probe will be withdrawn and biopsy forceps and puncture biopsy needle will be used to obtain samples at the target locations respectively.
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Combined Diagnostic yield
Diagnostic yield is defined as the proportion of nodules diagnosed by combined technologies in all nodulesundergoing bronchoscopy biopsy.
Time frame: Six months
Diagnostic yield
Diagnostic yield is defined as the proportion of nodulesdiagnosed by forceps biopsy (or puncture biopsy) in all nodulesundergoing bronchoscopy biopsy.
Time frame: Six months
The success rate of biopsy
The success rate of biopsy is defined as the number of nodules with at least one qualified abnormal lung tissue that can be used for pathological diagnosis divided by the number of all nodules diagnosed by combined technologies.
Time frame: Immediately after bronchoscopy biopsy
Operation time of the bronchoscopy
The operation time of the bronchoscopy is defined as the total time from insertion of the bronchoscope to withdrawal of the bronchoscope.
Time frame: Immediately after bronchoscopy biopsy
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