The Analysis of the EBUS Scope as a Hybrid Bronchoscope

NCT02360306 | Completed

• 1 other identifier: NA_00081049
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is widely used in the diagnosis of mediastinal and hilar adenopathy as well as in staging in lung cancer patients. Many studies have confirmed the utility of EBUS-TBNA with high sensitivity, specificity, and accuracy for the diagnosis of mediastinal and hilar adenopathy. 1-3 Less well reported has been the use of the EBUS bronchoscope to perform other procedures such as transbronchial biopsy (TBBx), endobronchial biopsy (EBBx), bronchoalveolar lavage (BAL) and airway brushings. While not well reported in the medical literature, anecdotal evidence supports these practices. The investigators propose a methodological evaluation of the full spectrum of procedures that have been performed and that are possible using an EBUS bronchoscope.

Conditions

Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• Procedures able to be performed succesfully by Hybrid EBUS

  Procedures able to be performed succesfully by Hybrid EBUS in comparison to Conventional EBUS. This will be assessed using a case report form that includes a checklist of various procedures (e.g. TBNA, transbronchial forcep biopsy)

  twelve months

Study Arms (2)

Conventional EBUS

ACTIVE COMPARATOR

Subjects in this arm will have endobronchial ultrasound bronchoscopy done by the conventional EBUS scope rather than the hybrid EBUS scope. Subjects in this arm, like in the Hybrid EBUS arm, may or may not receive transbronchial forcep biopsies, airway brusings, and/or radial EBUS, depending on clinical need.

Procedure: Endobronchial Ultrasound

Hybrid EBUS

EXPERIMENTAL

Subjects in this arm will have endobronchial ultrasound bronchoscopy done by the hybrid EBUS scope rather than the conventional EBUS scope. Subjects in this arm, like in the conventional EBUS arm, may or may not receive transbronchial forcep biopsies, airway brusings, and/or radial EBUS, depending on clinical need.

Procedure: Endobronchial Ultrasound

Interventions

Endobronchial Ultrasound PROCEDURE

Endobronchial ultrasound bronchoscopy with potential transbronchial needle aspiration, transbronchial forcep biopsy, brushing, or radial endobronchial ultrasound

Conventional EBUS; Hybrid EBUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing bronchoscopy involving the use of an EBUS bronchoscope in the Johns Hopkins endoscopy suite over the course of the study period

You may not qualify if:

• Patients not able to safely undergo bronchoscopy as judged by the Interventional Pulmonary service and Anesthesia. This follows standard clinical practice

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Lymphadenopathy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lonny Yarmus, DO

  Johns Hopkins 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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: February 10, 2015
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

US (1)