Needle Size Impact on EBUS-TBNA for Sarcoidosis and Lymphoma

Overseen By Thomas Vandemoortele, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Under 18, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two needle sizes used in a procedure called EBUS-TBNA, which diagnoses conditions like sarcoidosis and lymphoma. The researchers aim to determine if the larger ViziShot FLEX 19G needle provides better tissue samples than the standard 22G needle. Suitable candidates for this trial include individuals referred for a procedure to check for sarcoidosis or lymphoma and who have enlarged lymph nodes in specific chest areas. As an unphased trial, it offers participants the chance to contribute to improving diagnostic techniques for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on blood thinners (anticoagulants), you may need to stop them temporarily for the procedure.

What prior data suggests that this technique is safe for diagnosing sarcoidosis and lymphoma?

Research has shown that the ViziShot FLEX 19G needle, used in certain lung procedures, is generally well-tolerated. A three-year study reported no major complications immediately after using this needle. However, some batches were recalled due to bent tips, which could pose safety risks. Despite this, when used properly, the needle aims to improve tissue sampling for better diagnosis.

The standard 22G needle, used for similar procedures, has been in use longer and is also considered safe. Both needles assist doctors in obtaining better samples, but the 19G is designed to collect more tissue, which can aid in diagnosing conditions like sarcoidosis and lymphoma. Patients should discuss any concerns with their healthcare provider to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how needle size could impact the effectiveness of EBUS-TBNA procedures for diagnosing conditions like sarcoidosis and lymphoma. Unlike standard procedures that typically use a 22G needle, this trial introduces the ViziShot FLEX 19G needle, which is more flexible and potentially more effective at sampling lymph nodes. This could lead to more accurate diagnosis and better outcomes for patients, offering a promising advancement in how these conditions are assessed.

What evidence suggests that the ViziShot FLEX 19G needle is effective for diagnosing sarcoidosis and lymphoma?

Research has shown that the ViziShot FLEX 19G needle, which participants in this trial may receive, can enhance the quality of tissue samples taken during certain medical procedures. Its larger size and flexibility help doctors obtain better samples for diagnosing conditions like sarcoidosis and lymphoma. Studies have found that it collects more cells, aiding doctors in making more accurate diagnoses. Meanwhile, the Vizishot 22G needle serves as a standard comparator in this trial. The 19G needle also improves disease identification compared to smaller needles. Overall, the improved sample quality may lead to better treatment decisions. ^{2 3 5 6 7}

Who Is on the Research Team?

Thomas Vandemoortele, MD, MSc

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

This trial is for adults with suspected or recurring lymphoma, or sarcoidosis, evidenced by enlarged lymph nodes on imaging. Participants must be able to consent and tolerate the procedure. It excludes pregnant women, minors, those unable to consent, patients with significant coagulopathy or on non-suspendable anticoagulation therapy.

Inclusion Criteria

I am being tested for lymphoma for the first time or for a possible recurrence.

I am referred for a test due to suspected sarcoidosis or lymphoma, with certain lymph nodes appearing abnormal on scans.

My scans show lymph nodes larger than 0.5 cm.

Exclusion Criteria

My condition may be confirmed with a less invasive procedure like a lymph node or skin biopsy.

I am unable to give consent for medical procedures.

I am currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EBUS-TBNA using either the Vizishot 22G or Vizishot Flexneedle 19G for lymph node sampling

1 week

1 visit (in-person)

Follow-up

Participants are monitored for complications and diagnostic yield assessment

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Vizishot 22G needle
• ViziShot FLEX 19G needle

Trial Overview The study compares two needle sizes for EBUS-TBNA (a minimally invasive test using ultrasound-guided needles) in diagnosing sarcoidosis and lymphoma: a larger flexible 19G needle versus the standard smaller 22G needle.

How Is the Trial Designed?

Group I: Vizishot Flexneedle 19G Experimental Treatment 1 Intervention

Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle

Group II: Vizishot 22G Active Control 1 Intervention

Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle

ViziShot FLEX 19G needle is already approved in European Union, United States for the following indications:

Approved in European Union as ViziShot FLEX 19G needle for:

• Diagnostic use in EBUS-TBNA procedures

Approved in United States as ViziShot FLEX 19G needle for:

• Diagnostic use in EBUS-TBNA procedures

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

The study involved 11 patients and compared the diagnostic performance of a novel 19-G needle against 21- or 22-G needles in EBUS-TBNA, showing that the 19-G needle was effective in making definitive diagnoses in nine patients.

The 19-G needle successfully diagnosed conditions such as retinal hemangioblastoma and tuberculous lymphadenitis, and it was also useful for evaluating PD-L1 expression when previous smaller needle biopsies failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Clinical Performance of the New 19-G ViziShot FLEX and 21- or 22-G ViziShot 2 Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Needles. Minami, D., Ozeki, T., Okawa, S., et al.[2020]

In a study involving 189 patients, the AcquireTM needle used for EBUS-TBNB achieved a high diagnostic rate of 92.1%, with over 90% of samples providing adequate tissue for important ancillary studies, such as PD-L1 testing for lung cancer.

The AcquireTM needle demonstrated superior performance compared to the VizishotTM needle, which had a lower diagnostic rate of 85.1% and significantly fewer reported tissue cores, indicating that the AcquireTM may be a better option for evaluating mediastinal and hilar lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Asia-Pacific experience of trans-bronchial core biopsy with a Franseen needle. Brown, MV., Lavrencic, K., Badiei, A., et al.[2023]

In a study of 50 patients suspected of having sarcoidosis, EBUS-guided transbronchial needle aspiration (TBNA) showed a significantly higher diagnostic yield (83.3%) compared to standard TBNA with a 19-gauge needle (53.8%), indicating that EBUS is more effective for obtaining adequate tissue samples.

The EBUS-guided TBNA also demonstrated improved sensitivity (83.3%) compared to standard TBNA (60.9%), suggesting it is a more reliable method for diagnosing sarcoidosis in patients with mediastinal adenopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of standard vs endobronchial ultrasonography-guided transbronchial needle aspiration in patients with suspected sarcoidosis. Tremblay, A., Stather, DR., MacEachern, P., et al.[2017]

Transbronchial needle aspiration (TBNA) using the curvilinear array endobronchial ultrasound (EBUS) scope has shown increased diagnostic yield for lung cancer, with 9 out of 11 patients diagnosed effectively using this method.

In patients diagnosed with cancer, the EBUS-TBNA technique provided better quality and quantity of tumor cells compared to standard TBNA, suggesting that EBUS-TBNA is a highly effective and reliable procedure for lung cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Review of Different Methods of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration: A Preliminary Study. Wang, KP., Turner, ., Symanowski, J.[2012]

In a study involving 30 patients suspected of having sarcoidosis, the novel 22G crown-cut needle showed a similar overall diagnostic yield (77%) compared to the conventional 22G needle (82%), indicating that both tools are effective for diagnosis.

However, the crown-cut needle was better at detecting important histological features like granulomas and histiocytes, suggesting it may provide higher quality samples for evaluating granulomatous inflammation, despite some technical challenges and a minor bleeding incident during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a 22G Crown-Cut Needle with a Conventional 22G Needle with EBUS Guidance in Diagnosis of Sarcoidosis. Wälscher, J., Büscher, E., Bonella, F., et al.[2022]

In a study of 100 subjects with suspected sarcoidosis, the ProCore needle showed a higher diagnostic sensitivity (85.7%) compared to the standard needle (73.8%), but this difference was not statistically significant (p = 0.18).

Both needles provided similar rates of adequate aspirates (95.2% for ProCore vs. 90.5% for standard) and had comparable safety profiles, with one complication in each group, indicating no clear advantage of the ProCore needle over the standard needle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis. Dhooria, S., Sehgal, IS., Prasad, KT., et al.[2021]

A hybrid method using a 19-gauge needle for endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) was successfully performed on 10 patients with lung cancer, demonstrating its feasibility.

All samples collected using the 19G needle were adequate for both cytological and histopathological evaluation, suggesting that this approach may improve diagnostic yield in lung cancer assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound transbronchial needle aspiration: a hybrid method. Ben, S., Akulian, J., Wang, KP.[2022]

The use of the novel Flex 19G needle in EBUS-TBNA procedures resulted in a 100% diagnostic yield for cytology smears in 22 patients, with 68.2% diagnosed with malignancy, indicating its effectiveness for lung cancer diagnostics.

Endoscopists reported improved scope flexion and sample adequacy with the Flex 19G needle compared to standard 21/22G needles, while maintaining an acceptable safety profile with minimal bleeding observed during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Polish experience of Flexible 19 gauge Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration. Gnass, M., Sola, J., Filarecka, A., et al.[2018]

In a study involving 223 patients, the novel 22GUB needle design for EBUS-TBNA provided a larger number of tissue slices from biopsy sites compared to the traditional 21G needle, indicating improved sample collection efficiency.

The study introduced a new methodology for evaluating sample size by measuring the number of slices from constructed cell blocks, suggesting that needle design may be more important than just the volume of the sample collected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer biopsies: Comparison between simple 22G, 22G upgraded and 21G needle for EBUS-TBNA. Zarogoulidis, P., Petridis, D., Sapalidis, K., et al.[2020]

In a study of 15 patients suspected of having sarcoidosis, the use of the 19-G EBUS-TBNA needle achieved a high diagnostic yield of 93.3%, indicating its effectiveness for obtaining pathology specimens.

The study found that traditional transbronchial lung biopsy (TBLB) and endobronchial lung biopsy did not significantly improve diagnostic outcomes for sarcoidosis, suggesting that EBUS-TBNA may be a safer and more efficient option for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using 19-G Needle for Sarcoidosis. Balwan, A.[2018]

In a study involving 45 lesions, both the 21G and 22G needles used in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) showed equal effectiveness in detecting tumor cells, indicating similar diagnostic yields.

The 21G needle provided better preservation of histological structure in some samples, which could be beneficial for diagnosing certain conditions, although it also resulted in higher blood contamination compared to the 22G needle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 21-gauge and 22-gauge aspiration needle during endobronchial ultrasound-guided transbronchial needle aspiration. Nakajima, T., Yasufuku, K., Takahashi, R., et al.[2023]

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is significantly more effective than transbronchial lung biopsy (TBLB) for diagnosing sarcoidosis, with a pooled odds ratio of 5.89 based on a meta-analysis of 16 studies involving 1823 participants.

While EBUS-TBNA combined with other methods (TBLB and endobronchial biopsy) shows a higher diagnostic yield, there is no significant difference in effectiveness when compared to the combination of TBNA, TBLB, and endobronchial biopsy, suggesting flexibility in diagnostic approaches based on available resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration versus Standard Bronchoscopic Modalities for Diagnosis of Sarcoidosis: A Meta-analysis. Hu, LX., Chen, RX., Huang, H., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03573362

Effect of Needle Size in Diagnostic Yield of EBUS-TBNA ... For this study, the investigators want to compare the diagnostic yield of EBUS-TBNA using needle ViziShot FLEX 19G (1.11 mm) with that of the standard 22G ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6355416/

or 22-G ViziShot 2 Endobronchial Ultrasound-guided ... EBUS-TBNA with a 19-G needle was useful for diagnosing retinal hemangioblastoma and tuberculous lymphadenitis as well as for PD-L1 testing after 21- and 22-G ...

3. archbronconeumol.org archbronconeumol.org/en-three-year-experience-with-19-gauge-endobronchial-articulo-S1579212920301191

Three-Year Experience With the 19-Gauge Endobronchial ... The utility of endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (TBNA) for patients with suspected sarcoidosis is well established.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5949493/

Clinical evaluation of the utility of a flexible 19-gauge ... Our data would support that the Flex 19G needle can provide a significant improvement in cellularity and tissue volume to realize these ...

5. cdn.amegroups.cn cdn.amegroups.cn/journals/tgh/files/journals/28/articles/5671/public/5671-PB7-1876-R3.pdf

Endobronchial ultrasound needles: does size matter? suggest that the Flex 19G needle improves histopathologic analysis, which would allow for better subclassification of disease (14,15). Despite the theoretical ...

6. fda.gov fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endoscopic-aspiration-needle-recall-olympus-removes-certain-vizishot-2-flex-19g-needles-due

Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) ... Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are ...

7. olympusamerica.com olympusamerica.com/press-release/2025-09-19/olympus-issues-voluntary-recall-specific-lots-vizishot-2-flex-19g-ebus

Olympus Issues Voluntary Recall for Specific Lots ... The ViziShot 2 FLEX is designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy ...