Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle
NCT ID: NCT03004586
Last Updated: 2022-06-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2016-12-16
2020-06-25
Brief Summary
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The safety of the needles will also be studied.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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EBUS-TBNA:First Using a 25-Gauge Needle Then 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.
25-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
22-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.
EBUS-TBNA:First Using a 22-Gauge Needle Then 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.
25-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
22-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.
Interventions
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25-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
22-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.
Exclusion Criteria
2. Inability to give informed consent
3. Patients in which only one lymph node station is expected to be sampled by the performing clinician.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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George A. Eapen, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2017-00624
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0561
Identifier Type: -
Identifier Source: org_study_id
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