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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05512533
• Other study ID #: SHCHE202208
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: August 2022
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD., PhD.
• Phone: 86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Peripheral Pulmonary Nodules

Intervention

Device:
• Linear Ultrasound Bronchoscope BF-UC290F (Olympus)
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).

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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

Outcome

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