CompletedNot applicableNCT03311620

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).

Checked against the public recordLast updated Oct 8, 2020 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations1
SponsorFox Chase Cancer Center
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Fox Chase Cancer Center
Interventions being studied
Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2020. Always confirm current availability with the study team.

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