Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

Not Applicable

• Conditions: Lung Cancer
• Interventions: Device: Lung biopsy

• Registration Number: NCT04029155
• Lead Sponsor: Stefano Gasparini

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26
• Study Start: 2022-07-01
• Primary Completion: 2022-07-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TBNA with Conventional bronchoscope	Lung biopsy	patients in this arm will undergo bronchoscopy by a conventional probe
TBNA with a Ultrathin bronchoscope	Lung biopsy	Patients in this arm will undergo bronchoscopy by a ultra thin probe

Primary Outcome Measures

Name	Time	Method
Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm	through study completion, an average of 6 months	percentage

Secondary Outcome Measures

Name	Time	Method
Assess if diagnostic yield is higher in the "ultrathin" arm than in the "conventional" arm	through study completion, an average of 6 months	percentage