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

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).

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endobronchial ultrasound transbronchial needle aspirate	Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA); Biopsy samples will be collected from patients scheduled to undergo EBUS TBNA using 19g and 22g needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare diagnostic yield	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center

Publications and helpful links

General Publications

• Manley CJ, Kumar R, Gong Y, Huang M, Wei SS, Nagarathinam R, Haber A, Egleston B, Flieder D, Ehya H. Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology. J Am Soc Cytopathol. 2022 Mar-Apr;11(2):114-121. doi: 10.1016/j.jasc.2021.10.003. Epub 2021 Oct 23.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): June 8, 2020
• Study Completion (Actual): June 8, 2020

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TH-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No