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

Non Small Cell Lung Cancer Clinical Trial

Official title:

TH-112: Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311620
• Other study ID #: TH-112
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: June 8, 2020

Study information

• Verified date: October 2020
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 8, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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