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

Duke University

Status: Terminated

Conditions: Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy; ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION

Treatments: Device: 22 gauge Vizishot needles; Procedure: ROSE

Study type: Interventional

Funder types: Other

Identifiers

NCT02028052

Pro00036432

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

ROSE

Other group

Description:

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.

Treatment:

Procedure: ROSE

Device: 22 gauge Vizishot needles

NO ROSE

Other group

Description:

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

Treatment:

Procedure: ROSE

Device: 22 gauge Vizishot needles