Diagnostic Value of UTB and TB for PPL

Shanghai Jiao Tong University

Status: Completed

Conditions: Peripheral Pulmonary Lesion

Treatments: Procedure: Thin bronchoscope; Procedure: Ultrathin bronchoscope; Procedure: Guide sheath; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04571476

SHCHE202002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 578 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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578 participants in 3 patient groups

UTB-VBN-EBUS group

Experimental group

Description:

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.

Treatment:

Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound

Procedure: Ultrathin bronchoscope

TB-VBN-EBUS-GS group

Active Comparator group

Description:

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.

Treatment:

Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound

Procedure: Guide sheath

Procedure: Thin bronchoscope

TB-VBN-EBUS-non-GS group

Active Comparator group

Description:

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.

Treatment:

Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound

Procedure: Thin bronchoscope