EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions

Study Overview
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Brief Summary
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The aim of this study is to evaluate the diagnostic accuracy, safety and tolerability, predictors of success of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions. The Investigators will also evaluated the adequacy of samples obtained for molecular analysis in patients with Non-Small Cell Lung Cancer (NSCLC)

Detailed Description
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Lung cancer is by far the leading cause of cancer death among both men and women worldwide. Non-Small Cell Lung Cancer (NSCLC) represents about 80-90% of all lung cancers. Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is a safe and accurate technique that has been mostly described for the diagnosis and the mediastinal nodal staging of NSCLC, as a complementary technique to endobronchial ultrasound trans-bronchial needle aspiration (EBUS-TBNA) or when EBUS-TBNA may be difficult and/or contraindicated for clinical reasons (e.g. excessive cough, respiratory failure etc). Few retrospective studies evaluated the sensitivity and the safety of this technique in the diagnosis of parenchymal pulmonary lesions suspected for lung cancer, in contact or adjacent to the esophagus. Few data are available on the adequacy of the samples obtained by EUS-B-FNA for molecular analysis in NSCLC. The main predictors of success are still unclear. The primary aim of this prospective study is to evaluate the diagnostic accuracy of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions. The Investigators will also evaluate the safety and tolerability of the technique, the main predictors of success and the adequacy of samples obtained for molecular analysis in patients with NSCLC

Official Title
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Observational, Prospective, Multicenter Study on the Diagnostic Accuracy, Safety and Tolerability, Predictors of Success of EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: EUS-B-FNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with a lung parenchymal lesion suspected for malignancy, in contact or adjacent to the esophagus at the CT scan (with or without mediastinal lymph adenopathies), requiring a pathological diagnosis: which can not be sample by bronchoscopy/EBUS-TBNA or with a previous not diagnostic bronchoscopy/EBUS-TBNA or with clinical/anesthesiological contraindications to bronchoscopy/EBUS-TBNA or with a previous nodal EUS-B-FNA not diagnostic/not adequate at the ROSE Patients with lung parenchymal lesions who are able to sign the informed consent for the study participation Exclusion Criteria: Patients with lung parenchymal lesions of known etiology; Patients with lung parenchymal lesions in whom bronchoscopic ultrasound-guided trans- esophageal needle aspiration is contraindicated; Patients with lung parenchymal lesions who refuse/are not able to sign the informed consent for the study participation

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected lung cancer<br>Patients with pulmonary parenchymal lesions suspected for malignancy in contact or adjacent to the esophagus which can be sampled by EUS-B-FNA | Procedure: EUS-B-FNA<br>* Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is an endoscopic technique based on a trans-esophageal needle aspiration performed by an interventional pulmonologist with the echo-bronchoscope<br>* Other names: Endoscopic ultrasound with bronchoscope fine needle aspiration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of EUS-B-FNA in the detection of malignant pulmonary lesions | Diagnostic accuracy (i.e., sensitivity and specificity) of EUS-B-FNA in the diagnosis of malignant pulmonary parenchymal lesions, discriminating those with a malignant disease in comparison with those without the malignant disease. A specific unit of measure is not included, being the computation of the present outcome based on the absolute number of malignant/non malignant cases to the total number of diagnosed individuals. | At study completion (expected February 2021) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and relative frequency of adequate samples for molecular analysis in NSCLC following assessment by pathologist/molecular biologist | Proportional number (percentage) of samples obtained with EUS-B-FNA containing sufficient material (i.e. malignant cells) for molecular analysis in NSCLC following assessment by a pathologist/molecular biologist. A specific unit of measure is not included, being the computation of the present outcome based on the absolute number of malignant cells in the single sample. | At study completion (expected February 2021) | 
| Detection of predictors of successful aspirate based on the implementation of regression models | Implementation of regression models (logistic regression analysis) to detect variables related to a successful aspirate: anatomical (i.e. lung, lobe of the lesion), endoscopic (type of endoscope, type of needle, number of needle passes, needle aspiration technique), pathological (presence/absence of rapid on-site evaluation (ROSE), health personnel performing ROSE (i.e pathologist, respiratory physician, cytotechnician), pathological technique used for diagnosis and molecular analysis (smear, cell-block, liquid based cytology). A specific unit of measure is not included, being the computation of the present variables based on the measurement of absolute numbers not recorded with a specific unit of measure. The unit of measure is basically identified by the single element of the variable. | At study completion (expected February 2021) | 
| Safety (number of adverse events) of EUS-B-FNA through CTCAE v4.0 | Incidence rate and qualitative and quantitative description of adverse events in patients undergoing EUS-B-FNA. A specific unit of measure is not included, being the computation of the present outcome based on the absolute number of the adverse events detected by the attending physician. | Until 24 hours after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Endoscopic ultrasound, EUS-B-FNA, Molecular analysis, Rapid on-site evaluation