Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle

Study Overview
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Brief Summary
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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
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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: Participation on the study will be over after the bronchoscopy and EBUS-TBNA. This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The study doctor can explain how the needles are designed to work. Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.

Official Title
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Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle; A Randomized Controlled Trial

Conditions
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Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma, Lung Cancer

Intervention / Treatment
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* Device: 25-Gauge Needle
* Device: 22-Gauge Needle
* Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle<br>Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle. | Device: 25-Gauge Needle<br>* Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.<br>Device: 22-Gauge Needle<br>* Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.<br>Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)<br>* Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.<br>* Other names: EBUS-TBNA;|
| Experimental: EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle<br>Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle. | Device: 25-Gauge Needle<br>* Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.<br>Device: 22-Gauge Needle<br>* Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.<br>Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)<br>* Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.<br>* Other names: EBUS-TBNA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Lymph Nodes With Adequate Samples | 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. | One to two hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance With the Final Diagnosis | The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. 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. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis. | One to two hours | 
| Usability of the Needle | The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. 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. The participants are reported per intervention. | 1-2 hours (Intra procedurally) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma, Lung cancer, Ultrasound-guided transbronchial needle aspiration, EBUS-TBNA, 25-gauge needle, 22-gauge needle