Stylet Versus no Stylet in Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Diagnostic agreement (percentage of samples that have the same diagnosis)
Study Overview
Brief Summary
This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest.
The purpose of this research study is to determine if the EBUS-TBNA procedure can be made simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. Because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. If this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). This study is deigned to formally test the hypothesis that a stylet is not necessary in EBUS-TBNA.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients >18 years old and capable of informed consent refereed for EBUS-TBNA at our institution.
Exclusion Criteria
- •Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use, clinical instability)
- •Pregnant women
Arms & Interventions
EBUS patients
All patients in our study are in the same arm, as each patient serves as their own internal control. More specifically, each enrolled patient will receive both traditional EBUS (with the usage of stylet) and experimental EBUS (EBUS without a stylet) at each lymph node that is included in the experimental analysis.
Intervention: EBUS without stylet (Other)
Outcomes
Primary Outcomes
Diagnostic agreement (percentage of samples that have the same diagnosis)
Time Frame: At time of biopsy
The main outcome is the agreement (concordance) between the pathological diagnosis obtained by preforming EBUS with a stylet with EBUS without a stylet. Each patient will receive both techniques on each lymph node. We will then compare the diagnostic reached by each technique, and calculate the percentage of the time these techniques result in the same diagnosis.
Secondary Outcomes
- Pneumothorax rate (percentage of procedures that result in a pneumothorax)(1 week post-procedure)
- Bleeding rate (% of procedures that have significant bleeding)(1 week post-procedure)
- Hospital Admission (% of procedures that result in unanticipated admission to the hospital)(1 week post-procedure)