Diagnostic Value of UTB and TB for PPL

Not Applicable

Completed

• Conditions: Peripheral Pulmonary Lesion
• Interventions: Procedure: Ultrathin bronchoscope; Procedure: Thin bronchoscope; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound; Procedure: Guide sheath

• Registration Number: NCT04571476
• Lead Sponsor: Shanghai Chest Hospital

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 Timeline

• Study First Submitted: 2020-09-26
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-01
• Study Start: 2021-03-08
• Primary Completion: 2022-01-07
• Study Completion: 2022-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 578

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TB-VBN-EBUS-GS group	Guide sheath	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.
UTB-VBN-EBUS group	Ultrathin bronchoscope	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.
TB-VBN-EBUS-GS group	Thin bronchoscope	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.
TB-VBN-EBUS-non-GS group	Virtual bronchoscopic navigation combined with endobronchial ultrasound	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.
TB-VBN-EBUS-GS group	Virtual bronchoscopic navigation combined with endobronchial ultrasound	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.
TB-VBN-EBUS-non-GS group	Thin bronchoscope	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.
UTB-VBN-EBUS group	Virtual bronchoscopic navigation combined with endobronchial ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	Up to 6 months	Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions

Secondary Outcome Measures

Name	Time	Method
Duration of finding lesions	During the procedure	Duration of finding lesions defined from insertion of ultrasound probe to withdrawal of ultrasound probe
Feature of lesions	Up to 6 months	The feature of peripheral pulmonary lesions affecting the diagnostic yield includes the nature, size, location, the position of the ultrasound probe relative to the lesions etc.
Difference in the bronchus level reached with the bronchoscope	During the procedure	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
Complication rate	1 month	The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation.
Total examination time	During the procedure	Total examination time is defined from the time that the bronchoscope is inserted beyond the glottis, until the bronchoscope has been removed from the glottis after examination
Difference in diagnostic yield	Up to 6 months	Difference in diagnostic yield between thin bronchoscope with guide sheath combined small biopsy forceps and without guide sheath combined with conventional biopsy forceps.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China