128 Participants Needed

Needle Comparison for Diagnosing Sarcoidosis

JM
Overseen ByJudy McConnell
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.46789

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.478910

Who Is on the Research Team?

KY

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Menghini-type needleExperimental Treatment1 Intervention
Group II: Franseen-type needlesActive Control1 Intervention

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

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Approved in European Union as EBUS-TBNA for:
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Approved in United States as EBUS-TBNA for:
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Approved in Japan as EBUS-TBNA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Published Research Related to This Trial

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

Citations

Endobronchial ultrasound-guided transbronchial needle aspiration for the diagnosis of pulmonary sarcoidosis: A 9-year experience at a single center. [2023]
Yield of EBUS-TBNA for the diagnosis of sarcoidosis: impact of operator and cytopathologist experience. [2022]
Usefulness of endobronchial ultrasound-guided transbronchial needle aspiration for diagnosis of sarcoidosis. [2021]
A randomized controlled trial of standard vs endobronchial ultrasonography-guided transbronchial needle aspiration in patients with suspected sarcoidosis. [2017]
Real-time endobronchial ultrasound-guided transbronchial needle aspiration is useful for diagnosing sarcoidosis. [2022]
Severe Complications of Ultrasound Guided Transbronchial Needle Aspiration--A Case Series and Review of the Literature. [2017]
Efficacy and safety of convex probe EBUS-TBNA in sarcoidosis: a systematic review and meta-analysis. [2022]
Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. [2018]
Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. [2022]
[Diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration in pulmonary sarcoidosis]. [2018]
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