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The Analysis of the EBUS Scope as a Hybrid Bronchoscope

Primary Purpose

Lymphadenopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endobronchial Ultrasound
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphadenopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional EBUS

Hybrid EBUS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
November 7, 2014
Last Updated
February 5, 2015
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02360306
Brief Title
The Analysis of the EBUS Scope as a Hybrid Bronchoscope
Official Title
The Analysis of the EBUS Scope as a Hybrid Bronchoscope
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Objectives (include all primary and secondary objectives) Primary objective - To study and more fully describe the full spectrum of procedures performed using an EBUS bronchoscope outside of EBUS-TBNA. Background (briefly describe pre-clinical and clinical data, current experience with procedures, drug or device, and any other relevant information to justify the research) There currently exists only anecdotal evidence and individual reports of the use of EBUS bronchoscopes in the performance of non-EBUS-TBNA procedures. Given the full size working channel through which all standard bronchoscopic tools are able to pass, the EBUS bronchoscope has been reported to have been used in the performance of other procedures such as BAL, TBBx, EBBx and airway brushing. Frequently during bronchoscopic procedures in which EBUS-TBNA is used to sample lymph nodes within the hilum and mediastinum there exists a need to perform other procedures including but not limited to those listed above. In these cases, the EBUS bronchoscope is removed and exchanged for a standard video bronchoscope often times dirtying the scope for only a single procedure. We routinely use EBUS bronchoscopy in our daily practice as interventional pulmonologists and would like to study the use of these bronchoscopes in the performance of procedures other than TBNA perhaps in an effort to more fully understand the benefits and limitations associated with the use of an EBUS bronchoscope during conventional video bronchoscopy. Study Procedures Study design We plan to collect the data for all clinically indicated procedures using an EBUS bronchoscope over a twelve month time frame in the JHH outpatient endoscopy suite. No procedures will be performed for research purposes. No additional procedures will be performed outside the scope of standard practice. Study duration and number of study visits required of research participants. 12 month study duration, no research visits will be required. Justification of why participants will not receive routine care or will have current therapy stopped. All patients will receive routine standard of care. Justification for inclusion of a placebo or non-treatment group. The study is aimed at analyzing the data generated by clinically indicated procedures thus no placebo or non-treatment group has been included in the study. Drugs/ Substances/ Devices a. The rationale for choosing the drug and dose or for choosing the device to be used. The rationale for studying the EBUS bronchoscope and its application to non-TBNA procedures is to study the actual use of the scopes as well as to ascertain whether an EBUS scope is able to perform all bronchoscopic procedures thus decreasing the need for extra bronchoscopes and decreasing cleaning costs and wear on the devices. Benefits a. Description of the probable benefits for the participant and for society. There will be no direct benefit to the participants but society may benefit the medical society if EBUS bronchoscopes are shown to be able to perform the full range of bronchoscopic procedures as there may be decreased costs to the medical system as well as potential reduction in procedure time by eliminating the need to exchange scopes mid procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphadenopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional EBUS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hybrid EBUS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endobronchial Ultrasound
Intervention Description
Endobronchial ultrasound bronchoscopy with potential transbronchial needle aspiration, transbronchial forcep biopsy, brushing, or radial endobronchial ultrasound
Primary Outcome Measure Information:
Title
Procedures able to be performed succesfully by Hybrid EBUS
Description
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)
Time Frame
twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing bronchoscopy involving the use of an EBUS bronchoscope in the Johns Hopkins endoscopy suite over the course of the study period Exclusion Criteria: Patients not able to safely undergo bronchoscopy as judged by the Interventional Pulmonary service and Anesthesia. This follows standard clinical practice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonny Yarmus, DO
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Analysis of the EBUS Scope as a Hybrid Bronchoscope

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