Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02245295
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Sedation Technique in EBUS-TBNA
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: