Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

Stefano Gasparini

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: Lung biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04029155

UTB2019

Details and patient eligibility

About

This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.

Full description

142 patients with at least one peripheral pulmonary nodule will be enrolled. They will underwent randomization in 2 arms: patients in the first arm will undergo transbronchial needle aspiration with a conventional bronchoscope patients in the second arm will undergo transbronchial needle aspiration with a ultra-thin bronchoscope. Every bronchoscopy will be performed by the same operator and will contemplate 3 passes for each nodule, followed by Rapid On-Site Evaluation (ROSE) assessed by a dedicated cytologist. If the cytological on-site evaluation is negative in patients in the first arm, they will be shifted to the second arm. Histological and molecular diagnosis will be assessed by a dedicated pathologist. Data will be collected and analyzed.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18years;
• presence of at least one peripheral pulmonary lesion ≤ 3 cm on CT scan;
• ability to give an informed consent.

Exclusion criteria

• coagulopathy or bleeding diathesis that cannot be corrected;
• severe refractory hypoxemia;
• unstable hemodynamic status;
• inability to give an informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

TBNA with Conventional bronchoscope

Active Comparator group

Description:

patients in this arm will undergo bronchoscopy by a conventional probe

Treatment:

Device: Lung biopsy

TBNA with a Ultrathin bronchoscope

Experimental group

Description:

Patients in this arm will undergo bronchoscopy by a ultra thin probe

Treatment:

Device: Lung biopsy