Using ultrasound to assess lung lymph nodes in sarcoidosis patients
Role of Endobronchial Ultrasound Strain Elastography (EBUS-SE) in Sarcoidosis: a Prospective Cohort Study
This study is testing if a special ultrasound technique can help doctors better identify certain lymph nodes in patients with sarcoidosis to improve diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 701 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT04895111 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the use of endobronchial ultrasound strain elastography (EBUS-SE) to evaluate lymph nodes in patients with sarcoidosis. The study aims to determine if EBUS-SE can identify fibrotic lymph nodes, which may be associated with inadequate sampling during biopsies. By analyzing the elasticity of lymph nodes, the researchers hope to improve diagnostic accuracy and patient outcomes. The study will include patients with a clinical or radiological suspicion of sarcoidosis across various stages.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical or radiological suspicion of sarcoidosis.
Not a fit: Patients with severe bleeding disorders, recent uncontrolled cardiac disease, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the diagnostic accuracy for sarcoidosis and improve the quality of biopsy samples.
How similar studies have performed: Preliminary evidence from pilot studies suggests that similar approaches using elastography have shown promise in identifying fibrotic lymph nodes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * ASA physical status I-III. * Clinical/radiological (computed tomography) suspicion of sarcoidosis (Stages I to III) Exclusion Criteria: * Inability or unwillingness to consent. * Severe bleeding disorders * Contraindication for temporary interruption of the use of anticoagulant or antiplatelet therapy different from aspirin. * Recent and/or uncontrolled cardiac disease, uncontrolled pulmonary hypertension. * Compromised upper airway (eg, concomitant head and neck cancer or central airway stenosis for any reason). * Pregnancy
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Rocco Trisolini, MD
- Email: rocco.trisolini@policlinicogemelli.it
- Phone: +390630154204
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.