Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate

Completed · Not applicable

Conditions studied: Non Small Cell Lung Cancer

In brief

Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical markers and for mutational analysis. With regular use of immunotheraputic interventions, needle biospy has become more frequent and requires bigger samples for an increasing battery of tests. There has been no clear consensus on which biopsy needle yields the best biopsy sample. It is unclear if large 19g needle offers better yield than a 22 g needle. Although previous studies comparing 21, 22 and 19g needles have suggested that larger needles yield larger biopsy sizes, conflictng studies have shown that larger biopsies lead to bloodier samples with potentially smaller fragments of tissue, offering no improvement in diagnostic, yield, adequacy or sample size. This study compares biopsy samples collected using 19g and 22g needles from patients of non small cell lung cancer (NSCLC) scheduled to undergo endobronchial ultrasound (EBUS) and transbroncial needle aspiration (TBNA).

Key facts

Study ID

NCT03311620

Run by

Fox Chase Cancer Center

People needed

40

Starts

2018-05-15

Expected to finish

2020-06-08

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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