Comparing two types of needles for diagnosing sarcoidosis
A Prospective Randomized Clinical Trial Comparing Menghini-type Needle and Franseen-type Needle for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Pathological Diagnosis of Sarcoidosis
This study is testing whether a new type of needle works better than a standard needle for diagnosing sarcoidosis in patients with swollen lymph nodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06220526 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to compare the effectiveness of Franseen-type needles versus the conventional Menghini-type needles for diagnosing sarcoidosis through endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The study will enroll approximately 128 patients with enlarged mediastinal and/or hilar lymph nodes suspected of having sarcoidosis. Participants will be randomly assigned to receive either needle type, and the quality of the samples collected will be assessed by pathologists. The trial will also monitor procedural safety and efficiency, including total procedure time and the number of needle passes required.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with enlarged mediastinal and/or hilar lymph nodes suspected of sarcoidosis.
Not a fit: Patients with lymphadenopathy likely due to other diseases, such as lung cancer or infection, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy and efficiency for patients suspected of having sarcoidosis.
How similar studies have performed: While similar studies have explored needle types in EBUS-TBNA, this specific comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * -Any adult patient aged 18 years or older with enlarged mediastinal and/or hilar lymph nodes * (≥10 mm short-axis diameter on a CT scan), suspected as having sarcoidosis based on clinical * history, physical exam, and other investigations, and booked for EBUS-TBNA. Exclusion Criteria: * -Patients that are unable to provide informed consent \- Patients with lymphadenopathy strongly suspected to be secondary to other diseases based on * clinical history, physical exam, and/or other investigations (e.g., lung cancer, lymphoma, * infection).
Where this trial is running
Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kazuhiro Yasufuku — Uhn
- Study coordinator: Judy McConnell
- Email: judy.mcconnell@uhn.ca
- Phone: 416-581-7849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.