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

Temple University Health System (TUHS)

Status

Completed

Conditions

Non Small Cell Lung Cancer

Treatments

Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)

Study type

Interventional

Funder types

Other

Identifiers

NCT03311620

TH-112

Details and patient eligibility

About

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).

Full 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

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.