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Spots Global Cancer Trial Database for Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma

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Trial Identification

Brief Title: Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma

Official Title: Prospective Trial Comparing the Diagnostic Yield of Two Different Needle Sizes Used in EBUS-TBNA for Sarcoidosis and Lymphoma

Study ID: NCT03573362

Study Description

Brief Summary: The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . There is also a role in cases of isolated hilar and mediastinal lymph nodes in which the differential diagnosis includes mostly sarcoidosis, lymphoma and tuberculosis. 3 Various studies have evaluated more recently the diagnostic yield of EBUS-TBNA specifically for sarcoidosis 4 and thoracic lymphoma 5-6. Although there is emerging data supporting the usefulness of EBUS-TBNA in the investigation of these two pathologies, the efficacy results vary according to the target populations and certain parameters. Moreover, although a large randomized study demonstrated e superiority of EBUS-TBNA over conventional bronchoscopic sampling methods \[ bronchoalveolar lavage (BAL) and trans-bronchial biopsies (TBB \] for the diagnosis of sarcoidosis , 7 the results suggest that there is still room for optimizing the performance of EBUS-TBNA \[b\] . In the field of lymphoma, obtaining large enough specimens for adequate subtyping also remains a concern. 8 In order to improve the performance of EBUS -TBNA , new needles have been developed with the aim to provide biopsies for histological evaluation rather than purely cytological. The ViziShot FLEX © (Olympus) 19 gauge needle (19 gauge or 19G) is a large needle, which can provide both tissue and needle aspiration , and has the advantage of being more flexible. For this study, the investigators want to compare the diagnostic yield of EBUS-TBNA using needle ViziShot FLEX 19G (1.11 mm) with that of the standard 22G needle ( NA-201SX; Olympus) , in the investigation of hilar or mediastinal lymphadenopathy suspected to be sarcoidosis or lymphoma.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada

Contact Details

Name: Thomas Vandemoortele, MD, MSc

Affiliation: CHUM

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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