NCT02028052

Brief Summary

The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 15, 2017

Status Verified

January 1, 2015

Enrollment Period

2.6 years

First QC Date

December 20, 2013

Last Update Submit

February 14, 2017

Conditions

ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATIONBenign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy

Keywords

enlarged mediastinal nodesenlarged hilar lymph nodes

Outcome Measures

Primary Outcomes (1)

  • Time lapse

    The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal.

    during procedure, approximately 45 minutes

Secondary Outcomes (4)

  • Total number of sampled lymph nodes

    approximately 45 minutes

  • Average number of needle aspirations per lymph node sampled

    approximately 45 minutes

  • Overall diagnostic yield

    approximately 45 minutes

  • Procedural time of the cytopathologist

    approximately 30 minutes

Study Arms (2)

ROSE

OTHER

In the case of ROSE, sampling frequency will occur similarly, but no additional samples will be taken in the case of provision of a preliminary diagnosis.

Procedure: ROSEDevice: 22 gauge Vizishot needles

NO ROSE

OTHER

In the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site

Procedure: ROSEDevice: 22 gauge Vizishot needles

Interventions

ROSEPROCEDURE

The procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE.

NO ROSEROSE
22 gauge Vizishot needlesDEVICE
NO ROSEROSE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject provides informed consent
  • Subject is \>18 years of age
  • Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care
  • A negative pregnancy test in women of child-bearing potential
  • Subject is mentally capable of following study directions

You may not qualify if:

  • Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
  • Concurrent participation in another study involving investigational drugs or investigational medical devices
  • Inability to read and understand the necessary study documents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

  • Yasufuku K, Chiyo M, Sekine Y, Chhajed PN, Shibuya K, Iizasa T, Fujisawa T. Real-time endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. Chest. 2004 Jul;126(1):122-8. doi: 10.1378/chest.126.1.122.

    PMID: 15249452BACKGROUND

  • Mejia CP. [Surgery and orthodontics in the treatment of unerupted maxillary cuspids]. Rev Fed Odontol Colomb. 1976 Jan-Jun;24(116-117):47-52. No abstract available. Spanish.

    PMID: 1076725BACKGROUND

  • Griffin AC, Schwartz LE, Baloch ZW. Utility of on-site evaluation of endobronchial ultrasound-guided transbronchial needle aspiration specimens. Cytojournal. 2011;8:20. doi: 10.4103/1742-6413.90081. Epub 2011 Nov 21.

    PMID: 22145008BACKGROUND

  • Layfield LJ, Bentz JS, Gopez EV. Immediate on-site interpretation of fine-needle aspiration smears: a cost and compensation analysis. Cancer. 2001 Oct 25;93(5):319-22. doi: 10.1002/cncr.9046.

    PMID: 11668466BACKGROUND

Study Officials

  • Momen Wahidi, MD, MBA

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

January 6, 2014

Study Start

April 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 15, 2017

Record last verified: 2015-01

Locations

US(1)