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Brief Title: The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions
Official Title: Endobronchial Needle Aspiration With Rapid On-Site Evaluation in the Diagnosis of Central Malignant Lesions, a Randomized Controlled Trial
Study ID: NCT01456741
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, , Italy
Name: Michele Mondoni, MD
Affiliation: Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Role: STUDY_DIRECTOR
Name: Paolo Carlucci, MD
Affiliation: Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Role: STUDY_CHAIR
Name: Stefano Centanni, MD
Affiliation: Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Role: PRINCIPAL_INVESTIGATOR