View clinical trials related to Mediastinal Lymphadenopathy.
Filter by:Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the minimally invasive diagnostic modality for the evaluation of mediastinal and hilar lymph nodes (LNs). Traditionally, EBUS-TBNA is performed using either 21 gauge (G) or 22 G needle with a major limitation of inadequate sample especially when histologic assessment of tissue architecture is necessary such as in lympho-proliferative disorders and granulomatous inflammation. Although the specimen obtained with larger bore 19 G needle has been shown to be superior in terms of more cellular material and ability to subclassify malignant disease, it has more bloody samples. Recently a novel 22 G fine needle biopsy device (EBUS-FNB) has been introduced for endobronchial use after an experience gained from gastroenterology endoscopic ultrasound reporting high yield for core biopsies. FNB device has a unique design with 3 symmetrical, fully formed, cutting heels with 3 angled points to provide acquisition of FNB specimen in the form of a core tissue which might improve the overall diagnostic yield. Herein, investigators will study the diagnostic yield and safety of the 22 G EBUS-FNB needle with 19 G EBUS needle in the evaluation of mediastinal and hilar lymphadenopathy.
The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.
Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration is a procedure used to obtain tissue samples (biopsies) of lymph nodes near the airways or of lung tumours growing in close proximity to the airways. Briefly, an endoscope with an ultrasound probe which is inserted through the mouth and into the airways. Once in the airways, the ultrasound allows for identification of the optimal biopsy site; a hollow biopsy needle is then inserted into the tissue under real-time ultrasound visualization and a sample is extracted. In the investigator's centre, the extracted sample is then immediately subjected to rapid on-site evaluation (ROSE). During the ROSE procedure, a cytotechnologist uses part of the sample to make a limited number direct smears which are then rapidly stained and evaluated under a microscope by the cytotechnologist. The cytotechnologist provides an assessment of the adequacy of the sample for diagnosis. The respirologist performing the EBUS then uses this information to: i) determine whether additional sampling is required, and ii) triage any additional samples for ancillary studies as needed. A final cytopathological diagnosis is established several days later, when all of the material from the procedure (including the material not evaluated at ROSE) is examined by a cytopathologist. There are different techniques which are utilized to perform the needle aspiration biopsy. Suction aspiration (where pressure suction is applied to the needle to draw out material) which is the standard at many centres around the world and capilliary suction (where a tiny wire is drawn back slowly to create more gentle suction force) which is utilized often at LHSC. The purpose of this study is to evaluate for differences in ROSE adequacy between these two methods.
Participants who are scheduled to have an endo bronchial ultrasound (EBUS) trans bronchial needle aspiration (TBNA) will provide additional samples. These samples will then be sent to Imperial College London to see whether a cell line can be grown. If growth is successful then the samples will be returned to our pathology department to see if grading is possible and then to compare these results with the previous diagnostic samples. The cell line samples will not be used for patient diagnosis.
EUS-FNA is the recommended diagnostic examination of choice when patients present with suspected lower mediastinal lymph nodes on imaging. EUS-FNA is minimal invasive and low in costs, and although it has a good record in detecting diseases (eg confirm a nodal metastasis or granulomas) it has limitations in excluding diseases (missing metastases/ or granulomas) resulting in a false negative rate of 15-20%. Substantial limitations that most likely can be attributed to areas within the node that are not sampled during EUS-FNA tissue acquisition. Improved needle based EBUS/ EUS guided nodal diagnostics might result in improved quality of the fine needle aspirations, reduce in surgical diagnostic procedures , reduced costs and result in a shorter timebefore-treatment interval.
Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples when no suction is applied.
The main purpose of the present study is to assess whether the sensitivity of Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.