TH-112: Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fox Chase Cancer Center
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Compare diagnostic yield
Study Overview
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 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).
Detailed Description
Primary Objective To compare the diagnostic yield of 22g and 19g EBUS transbronchial needle aspirate (TBNA)
Secondary Objectives
- To compare the sample adequacy of 22g and 19g EBUS TBNA
- To compare the sample quality of 22g and 19 g EBUS TBNA
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
The needle size to be used first will be chosen by permuted block randomization scheme by the statistician
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Compare diagnostic yield
Time Frame: 1 year
Diagnostic yields of 22g and 19g needles will be evaluated by two blinded cytopathologists. Diagnostic yield refers to a specific diagnosis made on the basis of EBUS TBNA samples.
Secondary Outcomes
- To compare the sample adequacy of 22g and 19g EBUS TBNA(1 year)
- To compare the sample quality of 22g and 19 g EBUS TBNA(1 year)