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Completed

NCT Number: NCT02245295

The Role of Sedation Technique in 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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • EBUS-TBNA

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Moderate Sedation for EBUS/TBNA

Procedure

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

General anesthesia for EBUS/TBNA

Procedure

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

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 1-6 months

    Sensitivity, negative predictive value

Secondary outcomes

  1. Lymph node morphology

    Time frame: 1-6 months

    Impact of lymph node size on diagnostic accuracy

  2. EBUS technique

    Time frame: 1-6 months

    Impact of EBUS technique (number of needle passes) on diagnostic accuracy

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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