The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)
This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
31
A thin Olympus EBUS bronchoscope BF-UC290F will be used for all endobronchial ultrasound examinations, and biopsies will be conducted with EBUS needles - the ViziShot 2 22G (Olympus).
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Diagnostic yield of BF-UC290F for PPLs
Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.
Time frame: Up to 6 months
EBUS scope operation time
It is defined as the total time from insertion of the EBUS scope to withdrawal of the EBUS scope
Time frame: Immediately after each operation
The total time of lesion access
It is defined as the total time from the insertion of the EBUS scope to the arrival confirmed by ultrasound image.
Time frame: Immediately after Each Operation
Factors affecting the diagnosis rate
Factors affecting the diagnosis rate, including the nature of the lesions, the size of the lesions, the location of the lesions and so on will be analyzed.
Time frame: Up to 6 months
The bronchus level of lesions, and the bronchus level reached with the EBUS scope
Level: Main bronchus is level 0, lobar bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3
Time frame: During the procedure
Specimen adequacy
The adequacy of specimens obtained by Thin Convex Probe EBUS Scope BF-UC290F for pathological typing, molecular testing, and immune checkpoint detection
Time frame: Up to 6 months
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