The Analysis of the EBUS Scope as a Hybrid Bronchoscope

Lymphadenopathy Clinical Trial

Official title:

The Analysis of the EBUS Scope as a Hybrid Bronchoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360306
• Other study ID #: NA_00081049
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: February 5, 2015
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

1. 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.

2. 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.

3. Study Procedures

1. 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.

2. Study duration and number of study visits required of research participants. 12 month study duration, no research visits will be required.

3. Justification of why participants will not receive routine care or will have current therapy stopped.

All patients will receive routine standard of care.

4. 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.

4. 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.

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphadenopathy

Intervention

Procedure:
• Endobronchial Ultrasound
Endobronchial ultrasound bronchoscopy with potential transbronchial needle aspiration, transbronchial forcep biopsy, brushing, or radial endobronchial ultrasound

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No