The Role of Sedation Technique in EBUS-TBNA

Study Overview
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Brief Summary
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There is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar). The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with those on surgical or radiological follow-up.

Detailed Description
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Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes were enrolled. Demographic and clinical data, procedural reports and cytological findings were collected from medical records. Computed tomography (CT) or PET/CT scans were prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and radiological follow-up data.

Official Title
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Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Moderate Sedation for EBUS/TBNA
* Procedure: General anesthesia for EBUS/TBNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EBUS-TBNA Exclusion Criteria: No exclusion criteria

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EBUS-TBNA<br>EBUS-TBNA for enlarged mediastinal/hilar lymph nodes | Procedure: Moderate Sedation for EBUS/TBNA<br>* EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).<br>Procedure: General anesthesia for EBUS/TBNA<br>* EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Sensitivity, negative predictive value | 1-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node morphology | Impact of lymph node size on diagnostic accuracy | 1-6 months | 
| EBUS technique | Impact of EBUS technique (number of needle passes) on diagnostic accuracy | 1-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial endoscopy, ultrasound, EBUS, anesthesia, lung cancer, diagnosis including staging