The Role of Sedation Technique in EBUS-TBNA

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: Moderate Sedation for EBUS/TBNA; Procedure: General anesthesia for EBUS/TBNA

• Registration Number: NCT02245295
• Lead Sponsor: University of Zurich

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-19
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• EBUS-TBNA

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Exclusion Criteria

• No exclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA	General anesthesia for EBUS/TBNA	EBUS-TBNA for enlarged mediastinal/hilar lymph nodes
EBUS-TBNA	Moderate Sedation for EBUS/TBNA	EBUS-TBNA for enlarged mediastinal/hilar lymph nodes

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	1-6 months	Sensitivity, negative predictive value

Secondary Outcome Measures

Name	Time	Method
Lymph node morphology	1-6 months	Impact of lymph node size on diagnostic accuracy
EBUS technique	1-6 months	Impact of EBUS technique (number of needle passes) on diagnostic accuracy

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland