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Completed

NCT Number: NCT03311620

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).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)

Procedure

Biopsy samples will be collected from patients scheduled to undergo EBUS TBNA using 19g and 22g needles

Primary outcomes

  1. Compare diagnostic yield

    Time frame: 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 outcomes

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

    Time frame: 1 year

    Cytologic/ histologic analysis that determines the amount of sample collected with the two needles by two blinded cytopathologists

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

    Time frame: 1 year

    Sample quality will be examined by two blinded pathologists as to whether the samples contained only tissue or were contaminated with blood

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2017
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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