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

M.D. Anderson Cancer Center

Status: Completed

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

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03004586

NCI-2017-00624 (Registry Identifier)

2016-0561

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.

Exclusion criteria

1. Patients who are pregnant or lactating
2. Inability to give informed consent
3. Patients in which only one lymph node station is expected to be sampled by the performing clinician.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

61 participants in 2 patient groups

EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle

Experimental group

Description:

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.

Treatment:

Device: 22-Gauge Needle

Device: 25-Gauge Needle

Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)

EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle

Experimental group

Description:

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.

Treatment:

Device: 22-Gauge Needle

Device: 25-Gauge Needle

Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)