Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy
NCT ID: NCT03657849
Last Updated: 2023-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-07-18
2019-08-31
Brief Summary
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Detailed Description
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During this procedure, a special telescope (called a bronchoscope) is inserted through the mouth into the airways. Ultrasound technology allows the doctor to see the structures just outside the airway. By being able to see the structures outside the airway, the doctor is able to safely pass a fine needle through the airway to take samples of abnormal tissue.
EBUS-TBNA is used to take samples of tissue from the mediastinum. The mediastinum is the part of the chest between the lungs, and contains the heart, gullet, windpipe and lymph nodes. This area of the body is usually difficult to access without open surgery, hence the use of EBUS-TBNA. EBUS-TBNA may be used to investigate enlarged lymph nodes. This may be due to tuberculosis, sarcoidosis or cancer.
Currently, smaller 21-gauge and larger 19-gauge needles are used during the EBUS-TBNA procedure at Regions Hospital. The purpose of this study is to find out which needle is better in finding the explanation for the enlarged lymph nodes, and any follow up procedures that may be necessary if the investigators are unable to get enough tissue during the EBUS-TBNA procedure (surgical sampling, radiological sampling, and/or follow-up imaging).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Sampling with 19-gauge and 21-gauge
All patients will be allocated to the same arm. All patients will have EBUS TBNA done with both 19-gauge and 21-gauge needles during the procedure.
EBUS TBNA
All patients undergo EBUS TBNA with two needle sizes
Interventions
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EBUS TBNA
All patients undergo EBUS TBNA with two needle sizes
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Referred for EBUS TBNA sampling at Regions Hospital
Exclusion Criteria
* INR\>1.8 or platelets \<50K
18 Years
ALL
No
Sponsors
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HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Firas S Elmufdi, MBBS
Role: PRINCIPAL_INVESTIGATOR
Regions Hospital
Locations
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Regions Hospital
Saint Paul, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A18-177
Identifier Type: -
Identifier Source: org_study_id
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