The Role of Sedation Technique in EBUS-TBNA

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245295
• Other study ID #: EBUSEDA1
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: November 14, 2016
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: November 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• EBUS-TBNA

Exclusion Criteria:

• No exclusion criteria

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Moderate Sedation for EBUS/TBNA
EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).
• General anesthesia for EBUS/TBNA
EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Sensitivity, negative predictive value	1-6 months	No
Secondary	Lymph node morphology	Impact of lymph node size on diagnostic accuracy	1-6 months	No
Secondary	EBUS technique	Impact of EBUS technique (number of needle passes) on diagnostic accuracy	1-6 months	No