Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2018 |
| Start Date: | May 15, 2018 |
| End Date: | September 30, 2019 |
| Contact: | Christopher J Manley, MD |
| Email: | Christopher.Manley@fccc.edu |
| Phone: | 215-728-5703 |
TH-112: Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
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).
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).
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 compare the sample quality of 22g and 19 g EBUS TBNA
aspirate (TBNA)
Secondary Objectives
1. To compare the sample adequacy of 22g and 19g EBUS TBNA
2. To compare the sample quality of 22g and 19 g EBUS TBNA
Inclusion Criteria:
- 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 Criteria:
- 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.
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