NCT02245295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

Same day

First QC Date

September 15, 2014

Last Update Submit

November 14, 2016

Conditions

Lung Cancer

Keywords

Bronchial endoscopyultrasoundEBUSanesthesialung cancerdiagnosis including staging

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Sensitivity, negative predictive value

    1-6 months

Secondary Outcomes (2)

  • Lymph node morphology

    1-6 months

  • EBUS technique

    1-6 months

Study Arms (1)

EBUS-TBNA

EBUS-TBNA for enlarged mediastinal/hilar lymph nodes

Procedure: Moderate Sedation for EBUS/TBNAProcedure: General anesthesia for EBUS/TBNA

Interventions

Moderate Sedation for EBUS/TBNAPROCEDURE

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

EBUS-TBNA
General anesthesia for EBUS/TBNAPROCEDURE

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

EBUS-TBNA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with enlarged or suspicious mediastinal and/or hilar lymph nodes, in whom EBUS-TBNA is indicated

You may qualify if:

  • EBUS-TBNA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Conscious SedationAnesthesia, General

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaAnesthesia

Study Officials

  • Daniel Franzen, MD

    Division of Pulmonology

    PRINCIPAL INVESTIGATOR

  • Malcolm Kohler, Prof

    Division of Pulmonology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 19, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)