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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF-UC290F for diagnosing PPLs | Experimental | Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linear Ultrasound Bronchoscope BF-UC290F (Olympus) | Device | 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). |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: Complication rate | The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation | 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD., PhD. | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33447457 | Background | Zhi X, Wang L, Chen J, Zheng X, Li Y, Sun J. Scoring model of convex probe endobronchial ultrasound multimodal imaging in differentiating benign and malignant lung lesions. J Thorac Dis. 2020 Dec;12(12):7645-7655. doi: 10.21037/jtd-2020-abpd-005. | |
| 30610852 | Background | Fujino K, Ujiie H, Kinoshita T, Lee CY, Igai H, Inage T, Motooka Y, Gregor A, Suzuki M, Yasufuku K. First Evaluation of the Next-Generation Endobronchial Ultrasound System in Preclinical Models. Ann Thorac Surg. 2019 May;107(5):1464-1471. doi: 10.1016/j.athoracsur.2018.11.068. Epub 2019 Jan 2. |
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| 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: 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 | 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 |