- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245295
The Role of Sedation Technique in EBUS-TBNA
Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8091
- University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- EBUS-TBNA
Exclusion Criteria:
- No exclusion criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
EBUS-TBNA
EBUS-TBNA for enlarged mediastinal/hilar lymph nodes
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EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).
EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: 1-6 months
|
Sensitivity, negative predictive value
|
1-6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lymph node morphology
Time Frame: 1-6 months
|
Impact of lymph node size on diagnostic accuracy
|
1-6 months
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EBUS technique
Time Frame: 1-6 months
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Impact of EBUS technique (number of needle passes) on diagnostic accuracy
|
1-6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Franzen, MD, Division of Pulmonology
- Study Chair: Malcolm Kohler, Prof, Division of Pulmonology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBUSEDA1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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