Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle; A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Percentage of Lymph Nodes With Adequate Samples
Study Overview
Brief Summary
The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.
The safety of the needles will also be studied.
Detailed Description
As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign a separate consent for the bronchoscopy.
If participant agrees to take part in this study, before participant's bronchoscopy, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If participant is in Group 1, participant will have the EBUS-TBNA performed by first using a 25-gauge needle, followed by a 22-gauge needle.
- If participant is in Group 2, participant will have the EBUS-TBNA performed by first using a 22-gauge needle, followed by a 25-gauge needle.
To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide the needle into the area.
Length of Study:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.
Exclusion Criteria
- •Patients who are pregnant or lactating
- •Inability to give informed consent
- •Patients in which only one lymph node station is expected to be sampled by the performing clinician.
Arms & Interventions
EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.
Intervention: 22-Gauge Needle (Device)
EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.
Intervention: 25-Gauge Needle (Device)
EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.
Intervention: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) (Procedure)
EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.
Intervention: 25-Gauge Needle (Device)
EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.
Intervention: 22-Gauge Needle (Device)
EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.
Intervention: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) (Procedure)
Outcomes
Primary Outcomes
Percentage of Lymph Nodes With Adequate Samples
Time Frame: One to two hours.
The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.
Secondary Outcomes
- Usability of the Needle(1-2 hours (Intra procedurally))
- Concordance With the Final Diagnosis(One to two hours)