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

Trial Summary

What is the purpose of this trial?

This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle.

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 data supports the effectiveness of the treatment EBUS-TBNA for diagnosing sarcoidosis?

Research shows that EBUS-TBNA is a valuable and accurate method for diagnosing sarcoidosis, with studies reporting a high diagnostic yield. It is a minimally invasive technique that has been found to be more accurate than traditional methods in certain cases. ^{1 2 3 4 5}

Is EBUS-TBNA safe for diagnosing sarcoidosis?

EBUS-TBNA is generally considered safe and minimally invasive, but rare complications like mediastinitis (inflammation of the area between the lungs), pneumothorax (collapsed lung), and bleeding have been reported. ^{2 6 7 8 9}

How does the treatment EBUS-TBNA differ from other treatments for sarcoidosis?

EBUS-TBNA is a unique, minimally invasive procedure that uses ultrasound to guide a needle to collect tissue samples from the lungs, making it more accurate than traditional methods like standard needle aspiration or lung biopsies for diagnosing sarcoidosis. ^{1 2 3 4 10}

Research Team

Kazuhiro Yasufuku

Principal Investigator

UHN

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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) 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]

References

1. Netherlands 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Yield of EBUS-TBNA for the diagnosis of sarcoidosis: impact of operator and cytopathologist experience. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Usefulness of endobronchial ultrasound-guided transbronchial needle aspiration for diagnosis of sarcoidosis. [2021]

4. 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]

5. Australia pubmed.ncbi.nlm.nih.gov

Real-time endobronchial ultrasound-guided transbronchial needle aspiration is useful for diagnosing sarcoidosis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Severe Complications of Ultrasound Guided Transbronchial Needle Aspiration--A Case Series and Review of the Literature. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of convex probe EBUS-TBNA in sarcoidosis: a systematic review and meta-analysis. [2022]

8. Singapore 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. [2018]

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

Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. [2022]

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

[Diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration in pulmonary sarcoidosis]. [2018]