The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions

Study Overview
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Brief Summary
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Endobronchial lung cancer tend to manifest in three different patterns. It can present as a bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from peribronchial disease. Bronchoscopy with differents techniques as forceps biopsy, bronchial brushing and bronchial washing is recognized as the gold standard to diagnose central airways lung neoplasms. Some authors suggested that the addition of endobronchial needle aspiration (EBNA) to these conventional diagnostic methods may increase the sensitivity of bronchoscopy in submucosal and peribronchial disease but few prospective trials have been performed and this procedure is still underutilized in many centers. Rapid on-site evaluation (ROSE) showed to improve yield of transbronchial needle aspiration (TBNA) of mediastinal nodes and pulmonary peripheral lesions, reducing the number of inadequate specimens and costs. However, its utility during endobronchial needle aspiration has not been substantiated. This prospective study has two primary objectives: to compare the sensitivity of ROSE-EBNA with that of the conventional technique and to investigate the diagnostic yield of endobronchial needle aspiration and its contribution to CDM in the evaluation of patients with endobronchial lesions.

Official Title
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Endobronchial Needle Aspiration With Rapid On-Site Evaluation in the Diagnosis of Central Malignant Lesions, a Randomized Controlled Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: EBNA with ROSE
* Procedure: standard EBNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: consecutive adult patients with a suspected central lung cancer at a chest CT scan who need a bronchoscopy for diagnostic purposes Exclusion Criteria: presence of uncontrolled coagulopathy, preexisting known malignancies, and the refusal to sign 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-EBNA with ROSE<br> | Procedure: EBNA with ROSE<br>* The patients in this arm will undergo: A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence with rapid on-site evaluation B) if A will be negative transthoracic needle aspiration or surgical biopsy will be performed C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography<br>|
| Experimental: 1-EBNA without ROSE<br> | Procedure: standard EBNA<br>* The patients in this arm will undergo: A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence. B)if A will be negative transthoracic needle aspiration or surgical biopsy will be performed C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the sensitivity of the technique of endobronchial needle aspiration with rapid on-site evaluation for the diagnosis of endobronchial lung cancer | to determinate the sensitivity of endobronchial needle aspiration with rapid on-site evaluation compared to the conventional technique for the diagnosis of endobronchial lung cancer | 10 day | 
| the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods for the diagnosis of endobronchial lung cancer | to investigate the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods versus conventional diagnostic methods (bronchoscopy with forceps biopsies, bronchial brushing and bronchial washing) for the diagnosis of endobronchial lung cancer | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of rapid on-site evaluation on number of passes during endobronchial needle aspiration | study if the presence of rapid on-site evaluation during endobronchial needle aspiration may reduce the number of passes suggested by literature | 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endobronchial needle aspiration (EBNA), transbronchial needle aspiration (TBNA), rapid on-site evaluation (ROSE), lung cancer