Peripheral Pulmonary Nodules Clinical Trial
Official title:
Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions
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)
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 31, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Chest Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Chest Hospital |
China,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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