Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/24/2018 |
Start Date: | December 16, 2016 |
End Date: | December 2021 |
Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle; A Randomized Controlled Trial
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.
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.
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.
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.
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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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