Diagnostic Value of Ultrathin and Thin Bronchoscope for Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 578
- Locations
- 1
- Primary Endpoint
- Diagnostic yield
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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 (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.
Arms & Interventions
UTB-VBN-EBUS group
Ultrathin bronchoscope with a 3.0-mm outer diameter and a 1.7-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN and EBUS.
Intervention: Ultrathin bronchoscope (Procedure)
UTB-VBN-EBUS group
Ultrathin bronchoscope with a 3.0-mm outer diameter and a 1.7-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN and EBUS.
Intervention: Virtual bronchoscopic navigation combined with endobronchial ultrasound (Procedure)
TB-VBN-EBUS-GS group
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN-EBUS and a 1.95-mm outer diameter guide sheath.
Intervention: Thin bronchoscope (Procedure)
TB-VBN-EBUS-GS group
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN-EBUS and a 1.95-mm outer diameter guide sheath.
Intervention: Virtual bronchoscopic navigation combined with endobronchial ultrasound (Procedure)
TB-VBN-EBUS-GS group
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN-EBUS and a 1.95-mm outer diameter guide sheath.
Intervention: Guide sheath (Procedure)
TB-VBN-EBUS-non-GS group
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using conventional biopsy forceps and cytology brush with the guidance of VBN and EBUS, but without guide sheath.
Intervention: Thin bronchoscope (Procedure)
TB-VBN-EBUS-non-GS group
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using conventional biopsy forceps and cytology brush with the guidance of VBN and EBUS, but without guide sheath.
Intervention: Virtual bronchoscopic navigation combined with endobronchial ultrasound (Procedure)
Outcomes
Primary Outcomes
Diagnostic yield
Time Frame: Up to 6 months
Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions
Secondary Outcomes
- Feature of lesions(Up to 6 months)
- Duration of finding lesions(During the procedure)
- Difference in the bronchus level reached with the bronchoscope(During the procedure)
- Complication rate(1 month)
- Total examination time(During the procedure)
- Difference in diagnostic yield(Up to 6 months)
Investigators
Jiayuan Sun
Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital
Shanghai Chest Hospital