Evaluating needle size in lung biopsy for sarcoidosis and lymphoma

Prospective Trial Comparing the Diagnostic Yield of Two Different Needle Sizes Used in EBUS-TBNA for Sarcoidosis and Lymphoma

This study is testing whether using a bigger needle can help doctors get better tissue samples from patients suspected of having sarcoidosis or lymphoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT03573362 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of different needle sizes used in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on the diagnostic yield for patients suspected of having sarcoidosis or lymphoma. The study aims to compare the effectiveness of a 19G needle versus a standard 22G needle in obtaining tissue samples from lymph nodes. Patients with specific imaging findings and clinical suspicion of these conditions will be recruited to assess which needle size provides better diagnostic results. The trial is designed to enhance the accuracy of diagnosing these diseases through a minimally invasive procedure.

Who should consider this trial

Good fit: Ideal candidates are patients with clinical and radiological suspicion of sarcoidosis or lymphoma who have specific lymph node characteristics.

Not a fit: Patients unable to provide consent or those with contraindications to the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the diagnostic accuracy for patients with sarcoidosis and lymphoma, leading to better-targeted treatments.

How similar studies have performed: Previous studies have shown varying success with EBUS-TBNA in diagnosing sarcoidosis and lymphoma, indicating that this approach has potential but may require further validation.

Eligibility criteria

Inclusion criteria

* Patient t referred for specimens by EBUS -TBNA with clinical and radiological suspicion of sarcoidosis or lymphoma , with pathological lymph node on imaging (small diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal stations, sub-carinal and / or hilar (stations 2, 4, 7, 10, 11 and 12), right and / or left.
* Lymph nodes with a small diameter of at least 0.5 cm in CT-scan or PET / CT scan performed in the previous 4-6 weeks.
* Patient investigated in the setting of either an initial diagnosis or a suspicion of lymphoma recurrence (post-treatment).
* Patient able to consent to the procedure and to authorize us by written proxy, included in the consent form for the study, to obtain a copy of the subsequent results or radiological (PET, CT-scan, chest X-ray) or histopathological (linked with age sampled of intrathoracic lymph nodes).
* Patient deemed fit to tolerate the procedure.

Exclusion criteria

* Patient unable to give consent.
* Female patient during pregnancy
* Patient aged under 18.
* Patient with significant coagulopathy ( INR \> 1.5 ; platelet count\<50 000 / mm 3 ).
* Patient anticoagulated (oral or parenteral) and whose anticoagulation can not be suspended for the procedure.
* Obvious involvement of organ (s) with the possibility of confirming granulomas or suspicious cells of lymphoma by means of a procedure considered less invasive (.. e g, lymph node biopsy of cervical, supraclavicular or inguinal nodes; skin biopsy).

Where this trial is running

Montreal, Quebec

• Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Thomas Vandemoortele, MD, MSc — CHUM
• Study coordinator: Thomas Vandemoortele, MD, MSc

Conditions: Sarcoidosis, Lymphoma, Adenopathy Hilar, sarcoidosis, ebus, endobronchial ultrasound