Needle Comparison for Diagnosing Sarcoidosis
Recruiting in Palo Alto (17 mi)
Overseen byKazuhiro Yasufuku
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Disqualifiers: Lung cancer, Lymphoma, Infection, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
26789How 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.
123410Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Menghini-type needleExperimental Treatment1 Intervention
the standard needle type
Group II: Franseen-type needlesActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto General HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Endobronchial ultrasound-guided transbronchial needle aspiration for the diagnosis of pulmonary sarcoidosis: A 9-year experience at a single center. [2023]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is valuable for diagnosing pulmonary sarcoidosis. We aimed to evaluate the diagnostic yield of EBUS-TBNA and cytology in sarcoidosis during the first 9 years at our institution.
Yield of EBUS-TBNA for the diagnosis of sarcoidosis: impact of operator and cytopathologist experience. [2022]Studies have reported a high diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the diagnosis of sarcoidosis. We sought to review the yield of EBUS-TBNA for the diagnosis of sarcoidosis at our institution over time, and examine factors that may influence this yield.
Usefulness of endobronchial ultrasound-guided transbronchial needle aspiration for diagnosis of sarcoidosis. [2021]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an accurate and minimally invasive technique used routinely for investigation of mediastinal and hilar lymphadenopathy. However, few studies have addressed its role in comparison to the traditional diagnostic approaches of transbronchial lung biopsy (TBLB), endobronchial biopsy (EBB), and bronchoalveolar lavage (BAL) in the diagnosis of sarcoidosis. We evaluated the usefulness of EBUS-TBNA in the diagnosis of sarcoidosis compared to TBLB, EBB, and BAL.
A randomized controlled trial of standard vs endobronchial ultrasonography-guided transbronchial needle aspiration in patients with suspected sarcoidosis. [2017]Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) of mediastinal lymph nodes has been found to be more accurate than standard TBNA in the setting of malignancy. In patients with suspected sarcoidosis, the smaller ultrasound needle may yield inadequate material to make a histologic diagnosis of granulomatous inflammation. The aim of this study was to compare the diagnostic yield of EBUS-guided TBNA to TBNA performed with a standard 19-gauge needle in patients with mediastinal adenopathy and a clinical suspicion of sarcoidosis.
Real-time endobronchial ultrasound-guided transbronchial needle aspiration is useful for diagnosing sarcoidosis. [2022]Several studies of real-time endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) have reported a sensitivity of approximately 90% in the diagnosis of mediastinal and hilar malignancies. However, few studies have addressed its role in the diagnosis of sarcoidosis. The aim of the present study was to assess the utility of EBUS-TBNA in confirming a pathological diagnosis of sarcoidosis.
Severe Complications of Ultrasound Guided Transbronchial Needle Aspiration--A Case Series and Review of the Literature. [2017]Endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) has become essential for the workup of patients with lung cancer and other pulmonary diseases. The emphasis of currently available literature is related to the diagnostic yield of EBUS-TBNA which was found to be high. Complications seem to be rare but such data are scant. We report three cases of complications including mediastinitis, pneumothorax and bleeding and provide a review on the existing literature.
Efficacy and safety of convex probe EBUS-TBNA in sarcoidosis: a systematic review and meta-analysis. [2022]Real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive technique for diagnosis of mediastinal lymphadenopathy. Although most studies have reported the utility of EBUS-TBNA in malignancy, its use has been extended to benign conditions including sarcoidosis. Herein, we perform a systematic review and meta-analysis of studies reporting the diagnostic yield and safety of EBUS-TBNA in sarcoidosis.
Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. [2018]To evaluate diagnostic yield and the safety of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for mediastinal/hilar lymph nodes and intrapulmonary masses.
Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. [2022]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a safe and minimally invasive diagnostic tool for mediastinal and hilum evaluation. However, infectious complications may occur after EBUS-TBNA. Among these, mediastinitis and pericarditis are rare.
[Diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration in pulmonary sarcoidosis]. [2018]The aim of this study was to observe the diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in sarcoidosis.