Needle Comparison for Diagnosing Sarcoidosis

Overseen By Judy McConnell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Lung cancer, Lymphoma, Infection, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of needles to determine which collects better samples for diagnosing sarcoidosis, a condition where cell lumps grow in the body, often in the lungs. It compares the standard Menghini-type needle with the Franseen-type needle during EBUS-TBNA (Endobronchial Ultrasound-guided Transbronchial Needle Aspiration), a procedure that examines lung tissue. The goal is to determine if the Franseen-type needle provides clearer samples for diagnosis. Adults with enlarged lymph nodes in the chest and suspected sarcoidosis may be suitable for this trial. As an unphased trial, this study allows participants to contribute to important research that could enhance diagnostic techniques for sarcoidosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Franseen-type needle is safe for diagnosing sarcoidosis?

Research has shown that the Franseen-type needle is well-tolerated by patients. Studies indicate it collects tissue samples more effectively, with a lower chance of breaking them apart. This needle also provides higher accuracy in diagnosing non-cancerous conditions like sarcoidosis. Importantly, these studies have reported no major safety issues, suggesting it is safe for use in procedures like EBUS-TBNA, a type of bronchoscopy that uses ultrasound to take lung tissue samples. Overall, the Franseen-type needle appears effective without adding risk for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two needle types, the Menghini-type and the Franseen-type, used in EBUS-TBNA for diagnosing sarcoidosis. EBUS-TBNA, or endobronchial ultrasound-guided transbronchial needle aspiration, is a minimally invasive technique already used to sample lung tissue. The Menghini-type needle is the standard, but the Franseen-type is being tested as a potential improvement. Researchers hope to find out if the Franseen-type needle can provide better tissue samples or improve diagnostic accuracy, which could lead to more effective and less invasive diagnoses for patients with sarcoidosis.

What evidence suggests that Franseen-type needles are effective for diagnosing sarcoidosis?

This trial will compare the effectiveness of different needle types for diagnosing sarcoidosis. Research has shown that the Franseen-type needle, used by participants in one arm of this trial, might improve sample quality for diagnosing sarcoidosis. Studies have found that this needle often results in more accurate benign diagnoses compared to standard needles, helping pathologists see clearer results when examining tissue samples. The needle is also known for safely collecting sufficient tissue during procedures. While some studies report no major difference in diagnosis rates, the Franseen needle's ability to gather better samples might enhance diagnosis accuracy in certain cases. ^{6 7 8 9 10}

Who Is on the Research Team?

Kazuhiro Yasufuku

Principal Investigator

UHN

Are You a Good Fit for This Trial?

This trial is for individuals with sarcoidosis, a condition where tiny clumps of inflammatory cells grow in different parts of the body. Participants should be suitable candidates for a procedure called EBUS-TBNA, which collects tissue samples from the lungs.

Inclusion Criteria

I am an adult with suspected sarcoidosis and enlarged lymph nodes, scheduled for an EBUS-TBNA procedure.

Exclusion Criteria

My swollen lymph nodes are likely due to another condition like lung cancer, lymphoma, or an infection.

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EBUS-guided transbronchial needle aspiration using either Menghini-type or Franseen-type needles

1 day

1 visit (in-person)

Post-procedural assessment

Post-procedural assessment in the endoscopy recovery room, including monitoring of vital signs, signs of bleeding, and pulmonary status

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EBUS-TBNA

Trial Overview The study is testing two types of needles used in EBUS-TBNA: Franseen-type and Menghini-type. It aims to determine if the Franseen needle provides better quality samples for diagnosing sarcoidosis compared to the conventional Menghini needle.

How Is the Trial Designed?

Group I: Menghini-type needle Experimental Treatment 1 Intervention

the standard needle type

Group II: Franseen-type needles Active Control 1 Intervention

the active comparator arm

EBUS-TBNA is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as EBUS-TBNA for:

• Mediastinal and hilar lymph node staging for non-small cell lung cancer

Approved in United States as EBUS-TBNA for:

• Mediastinal and hilar lymph node staging for non-small cell lung cancer

Approved in Japan as EBUS-TBNA for:

• Mediastinal and hilar lymph node staging for non-small cell lung cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) demonstrated a high sensitivity of 96.67% for accurately distinguishing between benign and malignant lymph nodes and thoracic masses in a study of 95 patients.

The procedure was found to be safe, with no major complications reported, making it an effective diagnostic tool for lung cancer in patients with mediastinal/hilar lymphadenopathy and intrapulmonary masses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. Sun, J., Zhang, J., Zhao, H., et al.[2018]

In a study of 15 patients suspected of having sarcoidosis, EBUS-TBNA successfully identified non-caseating epithelioid cell granulomas in 93% of cases, confirming the diagnosis in 13 out of 14 patients.

The procedure was found to be safe, with no complications reported, making EBUS-TBNA a less invasive and effective method for diagnosing sarcoidosis compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time endobronchial ultrasound-guided transbronchial needle aspiration is useful for diagnosing sarcoidosis. Oki, M., Saka, H., Kitagawa, C., et al.[2022]

A systematic review of 15 studies involving 553 patients found that EBUS-TBNA has a pooled diagnostic yield of 79% for sarcoidosis, indicating it is an effective method for diagnosis.

The procedure is considered safe, with only five minor complications reported, suggesting that EBUS-TBNA can be routinely used for diagnosing sarcoidosis with minimal risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of convex probe EBUS-TBNA in sarcoidosis: a systematic review and meta-analysis. Agarwal, R., Srinivasan, A., Aggarwal, AN., et al.[2022]

EBUS-TBNA is generally a safe and minimally invasive procedure for diagnosing lymph node issues, but there is a risk of rare infectious complications like mediastinitis and pericarditis, even with prophylactic antibiotics.

In this case, a 67-year-old woman developed a mediastinal abscess and pericardial effusion after EBUS-TBNA, requiring intensive treatment, highlighting the need for awareness of these potential complications post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. Koh, JS., Kim, YJ., Kang, DH., et al.[2022]

Endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) is a highly effective diagnostic tool for lung cancer and other pulmonary diseases, with a high diagnostic yield reported in the literature.

While complications from EBUS-TBNA are rare, this study highlights three specific cases of complications—mediastinitis, pneumothorax, and bleeding—indicating that while the procedure is generally safe, there are potential risks that should be acknowledged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Complications of Ultrasound Guided Transbronchial Needle Aspiration--A Case Series and Review of the Literature. Giesa, C., Heining, L., Hecker, E., et al.[2017]

In a study of 43 patients undergoing 45 EBUS-TBNA procedures for suspected sarcoidosis, the overall diagnostic yield was 80%, indicating that this technique is effective for diagnosing the condition even without rapid on-site evaluation.

The diagnostic yield improved significantly with operator experience, particularly after the first 15 procedures, suggesting that skill and familiarity with the technique enhance the likelihood of accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yield of EBUS-TBNA for the diagnosis of sarcoidosis: impact of operator and cytopathologist experience. Navasakulpong, A., Auger, M., Gonzalez, AV.[2022]

EBUS-TBNA is an effective diagnostic tool for pulmonary sarcoidosis, achieving a yield rate of 72.1% for detecting nonnecrotizing granulomatous inflammation in samples from 68 procedures involving 80 patients.

The addition of cytology improved diagnostic sensitivity to 79.4%, indicating that combining EBUS-TBNA with cytological evaluation enhances the overall effectiveness of diagnosing sarcoidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided transbronchial needle aspiration for the diagnosis of pulmonary sarcoidosis: A 9-year experience at a single center. Shen, HS., Lin, FC., Tung, SM., et al.[2023]

In a study of 33 patients suspected of having sarcoidosis, EBUS-TBNA demonstrated a high diagnostic sensitivity of 90%, making it the most effective method compared to traditional techniques like TBLB (35%), EBB (6%), and BAL (71%).

The combination of EBUS-TBNA with TBLB and EBB achieved an overall diagnostic sensitivity of 94%, suggesting that EBUS-TBNA should be prioritized for histopathologic diagnosis of stage I and II sarcoidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of endobronchial ultrasound-guided transbronchial needle aspiration for diagnosis of sarcoidosis. Hong, G., Lee, KJ., Jeon, K., et al.[2021]

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]

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) demonstrated an 82% sensitivity for diagnosing sarcoidosis, significantly higher than the 53% sensitivity of standard bronchoscopy.

Combining EBUS-TBNA with standard bronchoscopy increased the overall diagnostic sensitivity to 88%, especially when targeting larger lymph nodes (≥ 2 cm) and performing at least 4 punctures, which achieved a 100% concordance rate with final results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration in pulmonary sarcoidosis]. Zhang, H., Wang, G., Zhang, W., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9526690/

Comparison of a 22G Crown-Cut Needle with a Conventional ... This study aimed to compare the novel 22G crown-cut needle with a conventional 22G needle with EBUS guidance in the diagnosis of sarcoidosis.

2. resmedjournal.com resmedjournal.com/article/S0954-6111(23)00019-7/fulltext

Endobronchial ultrasound bronchoscopy Franseen fine ... The Franseen EBUS core biopsy needle yielded a higher rate of benign diagnosis than that standard EBUS needle. · Higher volumes of non-small cell ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06220526/comparing-menghini-type-needle-and-franseen-type-needle-in-ebus-tbna-for-sarcoidosis

Comparing Menghini-type Needle and Franseen- ... This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11133993/

Comparison of 19-gauge conventional and Franseen ... Franseen needles have been reported to be useful for tissue sampling6-9,11; however, there was no significant difference in the diagnostic ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213294520300715

Core needle biopsy with endobronchial ultrasonography The Franseen needle evaluated in this study can safely procure core tissue samples during EBUS bronchoscopy that are adequate for histopathological diagnosis.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0954611123000197

Endobronchial ultrasound bronchoscopy Franseen fine ... Highlights. The Franseen EBUS core biopsy needle yielded a higher rate of benign diagnosis than that standard EBUS needle. Higher volumes of non-small cell ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10901641/

Comparison of diagnostic outcomes, safety, and cost ... Conclusions The Franseen-tip 19G outperforms 22G with a significantly lower fragmentation rate, longer AL, LIC, and a higher number of CPT with a marginal ...

8. link.springer.com link.springer.com/article/10.1007/s00408-022-00562-x

Comparison of a 22G Crown-Cut Needle with ... This study aimed to compare the novel 22G crown-cut needle with a conventional 22G needle with EBUS guidance in the diagnosis of sarcoidosis.

9. resmedjournal.com resmedjournal.com/article/S0954-6111(23)00019-7/pdf

Endobronchial ultrasound bronchoscopy Franseen fine ... Conclusion: The FNB needle demonstrated higher diagnostic yield in benign lymphadenopathy and higher quality for NGS than standard FNA needle. 1 ...

10. researchgate.net researchgate.net/publication/348508358_Diagnostic_yield_and_safety_of_the_ProCore_versus_the_standard_EBUS-TBNA_needle_in_subjects_with_suspected_sarcoidosis

Diagnostic yield and safety of the ProCore versus ... This needle seems to allow similar diagnostic accuracy as a standard 22-gauge needle for both malignancy and suspected sarcoidosis [114, 115] .