NCT03311620

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-15
• Primary completion: 2020-06-08
• Completion: 2020-06-08
• First posted: 2017-10-17
• Last updated: 2020-10-08

Locations

1 site across 1 country: United States