Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy

Study Overview
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Brief Summary
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To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy

Detailed Description
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There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging. Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance usually for the staging of lung cancer or evaluation of enlarged lymph nodes. In addition, lung lesions or masses can be visualized and biopsied in the same sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible bronchoscopy. It provides ultrasonographic images and permits needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

Official Title
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Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy

Conditions
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Mediastinal Lymphadenopathy

Intervention / Treatment
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* Procedure: EBUS with TBNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (18 Years and older) with mediastinal lymphadenopathy. Exclusion Criteria: known or suspected malignancy no informed consent pts with anterior mediastinal lesions contraindications to EBUS

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endobronchial ultrasound bronchoscopy<br>EBUS with TBNA | Procedure: EBUS with TBNA<br>* endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of EBUS-diagnosis | Sensitivity defined as the proportion of participants with a positive EBUS-diagnosis accordant to final diagnosis, specificity, positive predictive value, negative predictive value and accuracy will be determined | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors related with the development of complications | Complications during procedure as Bleeding, pneumothorax, shock cardiac arrhythmia, change of oxygen desaturation Complication after procedure as fever, mediastinitis, bleeding, pneumothorax and other complications after 24hr | 2 years | 
| Risk factors related with the procedure | dosage of sedative drugs Procedure time Total aspiration number Location of sampled lymph node Sampling number of lymph nodes the development of comorbidities Pulmonary function tests | 2 years |