Clinical trial NCT04571476: Diagnostic Value of UTB and TB for PPL
Official title: Diagnostic Value of Ultrathin and Thin Bronchoscope for Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Pulmonary Lesion
Keywords: Ultrathin bronchoscope
Thin bronchoscope
Peripheral pulmonary lesion
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: West China Hospital
name: Henan Provincial People's Hospital
First posted: 2020-10-01
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy.

Detailed description: The study aims to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) with the guidance of virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy. The study is designed as a prospective, multicenter, randomized controlled clinical trial. The participating centers are The First Affiliated Hospital of Guangzhou Medical University, Cancer Hospital Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, and Henan Provincial People's Hospital. Patients are divided into three groups: UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group. Each subject will be randomized to each group. The study is expected to enroll a total of 577 patients with 193, 192 and 192 in UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group, respectively.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old.
* Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) that need to be confirmed by pathology. The length diameter of the lesion is no less than 8 mm and no more than 5 cm.
* Patients without contraindications of bronchoscopy.
* Patients have good medical adherence and signed informed consent.

Exclusion Criteria:

* Peripheral pulmonary lesion is pure ground-glass opacity.
* Absence of bronchus leading to or adjacent to the lesion on thin-slice chest CT.
* Visible lumen lesions in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus).
* Diffuse pulmonary lesions.
* The investigators believe that patient has other conditions that are not suitable for the study.

Primary outcomes:
measure: Diagnostic yield
timeFrame: Up to 6 months
Secondary outcomes:
measure: Total examination time
timeFrame: During the procedure
measure: Duration of finding lesions
timeFrame: During the procedure
measure: Feature of lesions
timeFrame: Up to 6 months
measure: Difference in the bronchus level reached with the bronchoscope
timeFrame: During the procedure
measure: Difference in diagnostic yield
timeFrame: Up to 6 months
measure: Complication rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: Feng X, Zhang Q, Luo F, Zhang X, Zhang L, Xie F, Sun J, Li S. Study design for a multicenter, randomized controlled trial evaluating the diagnostic value of ultrathin bronchoscope compared to thin bronchoscope without fluoroscopy for peripheral pulmonary lesions. J Thorac Dis. 2022 May;14(5):1663-1673. doi: 10.21037/jtd-22-20.