Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Diagnostic yield of BF-UC290F for PPLs
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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 close to 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.
Arms & Interventions
BF-UC290F for diagnosing PPLs
Thin EBUS endoscope is inserted and used to visualize peripheral pulmonary lesions, and biopsies will be conducted by EBUS-TBNA.
Intervention: Linear Ultrasound Bronchoscope BF-UC290F (Olympus) (Device)
Outcomes
Primary Outcomes
Diagnostic yield of BF-UC290F for PPLs
Time Frame: Up to 6 months
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.
Secondary Outcomes
- EBUS scope operation time(Immediately after each operation)
- The total time of lesion access(Immediately after Each Operation)
- Factors affecting the diagnosis rate(Up to 6 months)
- The bronchus level of lesions, and the bronchus level reached with the EBUS scope(During the procedure)
- Specimen adequacy(Up to 6 months)
Investigators
Jiayuan Sun
Director, Department of Endoscopy
Shanghai Chest Hospital