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

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT03311620

Collaborator

(none)

Enrollment

Location

Arm

24.8

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)	N/A

Detailed Description

Primary Objective To compare the diagnostic yield of 22g and 19g EBUS transbronchial needle aspirate (TBNA)

Secondary Objectives

To compare the sample adequacy of 22g and 19g EBUS TBNA
To compare the sample quality of 22g and 19 g EBUS TBNA

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All abnormal lymph nodes able to be visualized by EBUS will be biopsied with sequential passes until a macroscopic specimen can be seen in the sample container. Each needle size will be used to take consecutive passes until the sample is complete and each pass will consist of 15-20 agitations. The needle size to be used first will be chosen by permuted block randomization scheme by the statistician. After all passes are done with the first needle, the alternate size needle will be used to biopsy the same lymph node. Samples will be placed in separate containers of formalin. Any subsequent lymph nodes in the same patient will be biopsied with the alternate sized needle first. Further, any lung nodules or masses that can be adequately visualized by EBUS where biopsy is clinically indicated will be sampled with both 22g and 19g TBNA needles in the same fashion. However, these lesions will be randomized separately from any lymph nodes biopsied during the case.All abnormal lymph nodes able to be visualized by EBUS will be biopsied with sequential passes until a macroscopic specimen can be seen in the sample container. Each needle size will be used to take consecutive passes until the sample is complete and each pass will consist of 15-20 agitations. The needle size to be used first will be chosen by permuted block randomization scheme by the statistician. After all passes are done with the first needle, the alternate size needle will be used to biopsy the same lymph node. Samples will be placed in separate containers of formalin. Any subsequent lymph nodes in the same patient will be biopsied with the alternate sized needle first. Further, any lung nodules or masses that can be adequately visualized by EBUS where biopsy is clinically indicated will be sampled with both 22g and 19g TBNA needles in the same fashion. However, these lesions will be randomized separately from any lymph nodes biopsied during the case.

Masking:

None (Open Label)

Masking Description:

The needle size to be used first will be chosen by permuted block randomization scheme by the statistician

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 15, 2018

Actual Primary Completion Date :

Jun 8, 2020

Actual Study Completion Date :

Jun 8, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111

Sponsors and Collaborators

Fox Chase Cancer Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fox Chase Cancer Center

ClinicalTrials.gov Identifier:

NCT03311620

Other Study ID Numbers:

TH-112

First Posted:

Oct 17, 2017

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Oct 8, 2020