Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Lung biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TBNA with Conventional bronchoscope<br>patients in this arm will undergo bronchoscopy by a conventional probe | Device: Lung biopsy<br>* Transbronchial Needle Aspiration performed via a ultra thin bronchoscope<br>|
| Experimental: TBNA with a Ultrathin bronchoscope<br>Patients in this arm will undergo bronchoscopy by a ultra thin probe | Device: Lung biopsy<br>* Transbronchial Needle Aspiration performed via a ultra thin bronchoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess if sensitivity is higher in the ultrathin arm than in the conventional arm | percentage | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess if diagnostic yield is higher in the ultrathin arm than in the conventional arm | percentage | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral pulmonary nodules, ultrathin bronchoscope, transbronchial needle aspiration