Lymphoma Clinical Trial
Official title:
Diagnostic Accuracy of Endobronchial Ultrasound Needle Aspiration With and Without Suction: a Single-center Randomized Controlled Trial
The main purpose of the present study is to compare the diagnostic yield of different aspiration techniques in Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) in the diagnosis of hilar/mediastinal adenopathy
Status | Not yet recruiting |
Enrollment | 306 |
Est. completion date | June 26, 2024 |
Est. primary completion date | June 26, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age = 18years; - presence of at least one hilar/mediastinal adenopathy >1 cm on short axis assessed by contrast-enhanced CT scan and/or hypermetabolic adenopathy assessed by FDG-PET; - ability to give an informed consent Exclusion Criteria: - coagulopathy or bleeding diathesis that cannot be corrected; - severe refractory hypoxemia; - unstable hemodynamic status; - inability to give an informed consent |
Country | Name | City | State |
---|---|---|---|
Italy | Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Ancona | Ancona |
Lead Sponsor | Collaborator |
---|---|
Università Politecnica delle Marche |
Italy,
He X, Wu Y, Wang H, Yu G, Xu B, Jia N, Yao Z. Slow-pull capillary technique versus suction technique in endobronchial ultrasound-guided transbronchial needle aspiration for diagnosing diseases involving hilar and mediastinal lymph node enlargement. Ther A — View Citation
Labarca G, Folch E, Jantz M, Mehta HJ, Majid A, Fernandez-Bussy S. Adequacy of Samples Obtained by Endobronchial Ultrasound with Transbronchial Needle Aspiration for Molecular Analysis in Patients with Non-Small Cell Lung Cancer. Systematic Review and Met — View Citation
Lin X, Ye M, Li Y, Ren J, Lou Q, Li Y, Jin X, Wang KP, Chen C. Randomized controlled trial to evaluate the utility of suction and inner-stylet of EBUS-TBNA for mediastinal and hilar lymphadenopathy. BMC Pulm Med. 2018 Dec 7;18(1):192. doi: 10.1186/s12890- — View Citation
Wahidi MM, Herth F, Yasufuku K, Shepherd RW, Yarmus L, Chawla M, Lamb C, Casey KR, Patel S, Silvestri GA, Feller-Kopman DJ. Technical Aspects of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: CHEST Guideline and Expert Panel Report. Che — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the diagnostic yield of active suction vs passive suction vs no suction EBUS-TBNA in the diagnosis of hilar/mediastinal adenopathies | The diagnostic yield is defined as the rate of diagnoses/total of cases. Assuming that the best technique provides a diagnostic yield of 94%, the non inferiority is defined if the difference between the best and the worst method is less than 3% with a non-inferiority limit of 10%. | 36 months | |
Secondary | Adeguacy for molecular assessment in lung cancer | Considering only the lung cancer diagnoses, the sample is considered adeguated is if provides all the available molecular evaluations included PD-L1 iperexpression | 36 months | |
Secondary | Qualitative evaluation of the sample by the pathologist | The sample is evaluated by a pathologist that provides a semi-quantitative assessment of the sample, through a cell count: the sample is adeguate only if it contains more than diagnostic 100 cells. | 36 months |
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