Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs

Study Overview
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Brief Summary
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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)

Detailed Description
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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 and quality, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.

Official Title
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Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions

Conditions
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Peripheral Pulmonary Nodules

Intervention / Treatment
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* Device: Linear Ultrasound Bronchoscope BF-UC290F (Olympus)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old. Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus/located at least 2 airway generations from the main carina as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are ≥5mm in diameter, thus BF-UC290F is able to arrival/access). Patients without contraindications of bronchoscopy. Patients have good medical adherence and signed informed consent. Exclusion Criteria: Peripheral pulmonary lesion is pure ground-glass opacity. Visible lumen lesions during bronchoscopy The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry The investigators believe that patient has other conditions that are not suitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF-UC290F for diagnosing PPLs<br>Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA. | Device: Linear Ultrasound Bronchoscope BF-UC290F (Olympus)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EBUS scope operation time | It is defined as the total time from insertion of the EBUS scope to withdrawal of the EBUS scope | 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. | 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. | Up to 6 months | 
| The bronchus level of lesions, and the bronchus level reached with the EBUS scope | 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 | 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 | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EBUS-TBNA, diagnostic yield, peripheral pulmonary nodules (PPLs)