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

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)

• Registration Number: NCT03311620
• Lead Sponsor: Fox Chase Cancer Center

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

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

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Start: 2018-05-15
• Primary Completion: 2020-06-08
• Study Completion: 2020-06-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endobronchial ultrasound transbronchial needle aspirate	Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)	-

Primary Outcome Measures

Name	Time	Method
Compare diagnostic yield	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 Outcome Measures

Name	Time	Method
To compare the sample adequacy of 22g and 19g EBUS TBNA	1 year	Cytologic/ histologic analysis that determines the amount of sample collected with the two needles by two blinded cytopathologists
To compare the sample quality of 22g and 19 g EBUS TBNA	1 year	Sample quality will be examined by two blinded pathologists as to whether the samples contained only tissue or were contaminated with blood

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States