NCT03004586

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma
• Lung Cancer

Interventions

Type	Name	Description
DEVICE	25-Gauge Needle	Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
DEVICE	22-Gauge Needle	Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
PROCEDURE	Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)	Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.

Timeline

• Start date: 2016-12-16
• Primary completion: 2020-06-25
• Completion: 2020-06-25
• First posted: 2016-12-29
• Last updated: 2022-06-22
• Results posted: 2022-06-22

Locations

1 site across 1 country: United States