Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Endobronchial ultrasound transbronchial needle aspirate
- interventionNames
- Procedure: Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)
Primary outcomes (1)
- measure
- Compare diagnostic yield
- timeFrame
- 1 year
- description
- 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 (2)
- measure
- To compare the sample adequacy of 22g and 19g EBUS TBNA
- timeFrame
- 1 year
- description
- Cytologic/ histologic analysis that determines the amount of sample collected with the two needles by two blinded cytopathologists
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDManley CJ, Kumar R, Gong Y, Huang M, Wei SS, Nagarathinam R, Haber A, Egleston B, Flieder D, Ehya H. 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. J Am Soc Cytopathol. 2022 Mar-Apr;11(2):114-121. doi: 10.1016/j.jasc.2021.10.003. Epub 2021 Oct 23. PMID 34896033