Novel Thin Bronchoscope Versus Ultrathin Bronchoscope for the Diagnosis of Peripheral Pulmonary Nodules

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Lung Cancer (Diagnosis)

Treatments: Device: Ultrathin bronchoscope (UTB); Device: Thin bronchoscope (TB1); Device: Thin bronchoscope (TB2)

Study type: Interventional

Funder types: Other

Identifiers

NCT07135297

IS25002

Details and patient eligibility

About

This is a prospective, randomised, non-inferior, multicenter study in consecutive patients with solid or sub-solid PPLs 8 to 30 mm in diameter.The subjects will be randomly assigned in a 1:1:1 ratio to the 3.0mm outer diameter/1.7mm forceps channel ultrathin bronchoscope group (UTB-VBN-EBUS group), the 3.3mm outer diameter/2.0mm forceps channel novel thin bronchoscope combined with guide sheath group (TB1-VBN-EBUS-GS group), and the 4.2mm outer diameter/2.8mm forceps channel novel thin bronchoscope combined with guide sheath group (TB2-VBN-EBUS-GS group). All procedures will be performed using UTB or TB with the guidance of virtual bronchoscopic navigation (VBN) combined with radial endobronchial ultrasound (rEBUS), but without fluoroscopy. A small forceps will be used in UTB-VBN-EBUS group and TB1-VBN-EBUS-GS group, while a standard forceps will be used in TB2-VBN-EBUS-GS group. Primary endpoint is the diagnostic yield.

Full description

This is a prospective, randomised, non-inferior, multicenter study. The inclusion criteria are patients whose chest imaging shows suspiciously malignant peripheral lung nodules (the nodules are surrounded by lung tissue and are located below the segmental bronchus), and the diameter of the lesion is between 8mm and 30mm. The subjects will be randomly assigned in a 1:1:1 ratio to the 3.0mm outer diameter/1.7mm forceps channel ultrathin bronchoscope group (UTB-VBN-EBUS group), the 3.3mm outer diameter/2.0mm forceps channel novel thin bronchoscope combined with guide sheath group (TB1-VBN-EBUS-GS group), and the 4.2mm outer diameter/2.8mm forceps channel novel thin bronchoscope combined with guide sheath group (TB2-VBN-EBUS-GS group). All procedures were performed using UTB or TB with the guidance of virtual bronchoscopic navigation (VBN) combined with radial endobronchial ultrasound (rEBUS), but without fluoroscopy. A small forceps was used in UTB-VBN-EBUS group and TB1-VBN-EBUS-GS group, while a standard forceps was used in TB2-VBN-EBUS-GS group. Primary endpoint is the diagnostic yield. The secondary endpoints include total examination time, the time from bronchoscope insertion of the glottis to the time of removing from the glottis; duration time of finding lesions, the time from insertion of ultrasound probe to withdrawal of ultrasound probe when a rEBUS view was seen; the proportion of lesions visible by rEBUS; factors affecting the diagnostic yield, difference in the bronchus level reached with the bronchoscope; difference in diagnostic yield; and complication rate. Complication rate includes adverse events related to the procedure during or within 1 month after the operation.

Enrollment: 465 estimated 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 30mm.
• 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 in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus).
• The target lesion has been treated.
• 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: Single Blind

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465 participants in 3 patient groups

UTB-VBN-EBUS

Experimental group

Description:

An ultrathin bronchoscope with an outer diameter of 3.0mm and a working channel of 1.7mm will be used in combination with VBN and EBUS. An outer diameter 1.5mm biopsy forceps and a 1.4mm cytology brush will be used for sample collection.

Treatment:

Device: Ultrathin bronchoscope (UTB)

TB1-VBN-EBUS-GS

Experimental group

Description:

A thin bronchoscope with an outer diameter of 3.3mm and a working channel of 2.0mm will be used in combination with VBN and EBUS. A guide sheath with an outer diameter of 1.95mm, a 1.5mm biopsy forceps, and a 1.4mm cytology brush will be used for sample collection.

Treatment:

Device: Thin bronchoscope (TB1)

TB2-VBN-EBUS-GS

Experimental group

Description:

A thin bronchoscope with an outer diameter of 4.2mm and a working channel of 2.8mm will be used in combination with VBN and EBUS. A guide sheath with an outer diameter of 2.55mm, a 1.9mm biopsy forceps, and a 1.8mm cytology brush will be used for sample collection.

Treatment:

Device: Thin bronchoscope (TB2)