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

Not Applicable

Completed

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

Interventions: Device: 25-Gauge Needle
Device: 22-Gauge Needle
Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Registration Number: NCT03004586

Lead Sponsor: M.D. Anderson Cancer Center

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:

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle	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.
EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle	Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)	Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.
EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle	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.
EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle	25-Gauge Needle	Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.
EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle	22-Gauge Needle	Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.
EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle	Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)	Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.

Primary Outcome Measures

Name	Time	Method
Percentage of Lymph Nodes With Adequate Samples	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 Outcome Measures

Name	Time	Method
Usability of the Needle	1-2 hours (Intra procedurally)	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.
Concordance With the Final Diagnosis	One to two hours	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.