Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) (ROSE)

February 14, 2017 updated by: Duke University

Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) by Cytopathologist

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject provides informed consent
  2. Subject is >18 years of age
  3. 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
  4. A negative pregnancy test in women of child-bearing potential
  5. Subject is mentally capable of following study directions

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ROSE
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: ROSE
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.
Device: 22 gauge Vizishot needles
Other: NO ROSE
In the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site
Procedure: ROSE
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.
Device: 22 gauge Vizishot needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time lapse
Time Frame: during procedure, approximately 45 minutes
The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal.
during procedure, approximately 45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of sampled lymph nodes
Time Frame: approximately 45 minutes
Samples taken during procedure
approximately 45 minutes
Average number of needle aspirations per lymph node sampled
Time Frame: approximately 45 minutes
Determined by tumor
approximately 45 minutes
Overall diagnostic yield
Time Frame: approximately 45 minutes
approximately 45 minutes
Procedural time of the cytopathologist
Time Frame: approximately 30 minutes
approximately 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Momen Wahidi, MD, MBA, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

January 3, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00036432

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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