Status:
COMPLETED
Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical markers and for mutational analysis. With regular use of immunotheraputic interventions, needle biospy has...
Detailed Description
Primary Objective To compare the diagnostic yield of 22g and 19g EBUS transbronchial needle aspirate (TBNA) Secondary Objectives 1. To compare the sample adequacy of 22g and 19g EBUS TBNA 2. To comp...
Eligibility Criteria
Inclusion
- Patients undergoing EBUS TBNA for evaluation of lymphadenopathy, lung nodule or mass
- Patients must have atypical lymph nodes. Atypical lymph nodes are characterized by \>10mm in short axis or lymph nodes 5-10mm in short axis with atypical features.
- Age \> 18 years.
- Patients must have platelets count \> 50,000
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- WOCBP must agree not to get pregnant until the day of the procedure
Exclusion
- Patients with uncorrectable coagulopathy will be excluded.
- Patients with hemodynamic instability will be excluded
- Patients with refractory hypoxemia will be excluded
- Patients with therapeutic anticoagulant that cannot be held for 2 days before and 1 day after the procedure.
- Patients who are unable to tolerate general anesthesia according to the anesthesiologist
- Pregnant or breast feeding.
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03311620
Start Date
May 15 2018
End Date
June 8 2020
Last Update
October 8 2020
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111