NCT03311620

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

Completed NA Last updated 8 October 2020

What this trial tests

NA trial testing Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA) in Non Small Cell Lung Cancer in 40 participants. Completed in 8 June 2020.

Timeline

15 May 2018

Primary endpoint
8 June 2020

8 June 2020

Quick facts

Lead sponsor	Fox Chase Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	40
Start date	15 May 2018
Primary completion	8 June 2020
Estimated completion	8 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

Fox Chase Cancer Center — full company profile →

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Manley CJ, Kumar R, Gong Y, Huang M, et al · · 2022 · cited 13× · PMID 34896033 · DOI 10.1016/j.jasc.2021.10.003