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

Trial Summary

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 data supports the effectiveness of the treatment using different needle sizes in EBUS-TBNA for diagnosing sarcoidosis and lymphoma?

The study found that using a 19-G needle in EBUS-TBNA was effective in diagnosing conditions like sarcoidosis and lymphoma, with successful diagnoses in patients where smaller needles had previously failed. This suggests that the larger 19-G needle may provide better diagnostic results for these conditions. ^{1 2 3 4 5}

Is the use of different needle sizes for EBUS-TBNA generally safe for humans?

The use of different needle sizes for EBUS-TBNA, including the ViziShot and ProCore needles, has been shown to be generally safe in humans, with only minor complications like transient hypoxemia (temporary low oxygen levels) reported. Larger studies are needed to confirm these findings, but current data suggests that these procedures are safe. ^{1 3 6 7 8}

How does the ViziShot FLEX 19G needle treatment differ from other treatments for sarcoidosis and lymphoma?

The ViziShot FLEX 19G needle is unique because it is a larger gauge needle used in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), which can improve diagnostic accuracy for conditions like sarcoidosis and lymphoma compared to the smaller 21- or 22-gauge needles typically used. This larger needle can provide more tissue for analysis, potentially leading to more definitive diagnoses. ^{1 9 10 11 12}

What is the purpose of this trial?

The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . There is also a role in cases of isolated hilar and mediastinal lymph nodes in which the differential diagnosis includes mostly sarcoidosis, lymphoma and tuberculosis. 3 Various studies have evaluated more recently the diagnostic yield of EBUS-TBNA specifically for sarcoidosis 4 and thoracic lymphoma 5-6. Although there is emerging data supporting the usefulness of EBUS-TBNA in the investigation of these two pathologies, the efficacy results vary according to the target populations and certain parameters. Moreover, although a large randomized study demonstrated e superiority of EBUS-TBNA over conventional bronchoscopic sampling methods \[ bronchoalveolar lavage (BAL) and trans-bronchial biopsies (TBB \] for the diagnosis of sarcoidosis , 7 the results suggest that there is still room for optimizing the performance of EBUS-TBNA \[b\] . In the field of lymphoma, obtaining large enough specimens for adequate subtyping also remains a concern. 8 In order to improve the performance of EBUS -TBNA , new needles have been developed with the aim to provide biopsies for histological evaluation rather than purely cytological. The ViziShot FLEX © (Olympus) 19 gauge needle (19 gauge or 19G) is a large needle, which can provide both tissue and needle aspiration , and has the advantage of being more flexible. 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 needle ( NA-201SX; Olympus) , in the investigation of hilar or mediastinal lymphadenopathy suspected to be sarcoidosis or lymphoma.

Research Team

Thomas Vandemoortele, MD, MSc

Principal Investigator

CHUM

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

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]

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]

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]

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]

References

1. Japan 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Review of Different Methods of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration: A Preliminary Study. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of a 22G Crown-Cut Needle with a Conventional 22G Needle with EBUS Guidance in Diagnosis of Sarcoidosis. [2022]

5. China pubmed.ncbi.nlm.nih.gov

First Asia-Pacific experience of trans-bronchial core biopsy with a Franseen needle. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Initial Polish experience of Flexible 19 gauge Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration. [2018]

7. Australia pubmed.ncbi.nlm.nih.gov

Lung cancer biopsies: Comparison between simple 22G, 22G upgraded and 21G needle for EBUS-TBNA. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Comparison of 21-gauge and 22-gauge aspiration needle during endobronchial ultrasound-guided transbronchial needle aspiration. [2023]

10. China pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound transbronchial needle aspiration: a hybrid method. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration versus Standard Bronchoscopic Modalities for Diagnosis of Sarcoidosis: A Meta-analysis. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of standard vs endobronchial ultrasonography-guided transbronchial needle aspiration in patients with suspected sarcoidosis. [2017]