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The Role of Sedation Technique in EBUS-TBNA

NCT ID: NCT02245295

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

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.

Conditions

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Lung Cancer

Keywords

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Bronchial endoscopy ultrasound EBUS anesthesia lung cancer diagnosis including staging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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EBUS-TBNA

EBUS-TBNA for enlarged mediastinal/hilar lymph nodes

Moderate Sedation for EBUS/TBNA

Intervention Type PROCEDURE

EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).

General anesthesia for EBUS/TBNA

Intervention Type PROCEDURE

EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)

Interventions

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Moderate Sedation for EBUS/TBNA

EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).

Intervention Type PROCEDURE

General anesthesia for EBUS/TBNA

EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* EBUS-TBNA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Franzen, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Pulmonology

Malcolm Kohler, Prof

Role: STUDY_CHAIR

Division of Pulmonology

Locations

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University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EBUSEDA1

Identifier Type: -

Identifier Source: org_study_id