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

Not Applicable

Terminated

• Conditions: ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION; Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy
• Interventions: Procedure: ROSE; Device: 22 gauge Vizishot needles

• Registration Number: NCT02028052
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NO ROSE	22 gauge Vizishot needles	In the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site
ROSE	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.
ROSE	22 gauge Vizishot needles	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.
NO ROSE	ROSE	In the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site

Primary Outcome Measures

Name	Time	Method
Time lapse	during procedure, approximately 45 minutes	The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States