Comparing two biopsy methods for diagnosing sarcoidosis in lymph nodes
Evaluating the Diagnostic Yield and Specimen Quality With Endobronchial Ultrasound-Guided Intranodal Forceps Biopsies in Patients With Mediastinal and Hilar Lymphadenopathy: A Prospective Analysis
This study is testing whether a new biopsy method can find sarcoidosis in lymph nodes better than the standard method for people who might have this condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | George Washington University Academic / other |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT05374447 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the diagnostic yield and specimen quality of endobronchial ultrasound-guided intranodal forceps biopsy (EBUS-IFB) with the standard transbronchial needle aspiration (EBUS-TBNA) in patients suspected of having sarcoidosis based on imaging. It is a prospective, single-center randomized study that will enroll 55 patients to assess whether EBUS-IFB provides a higher diagnostic yield than EBUS-TBNA. The study seeks to fill a knowledge gap regarding the effectiveness of these biopsy techniques in diagnosing mediastinal lymphadenopathy. The results could help refine diagnostic approaches for suspected sarcoidosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with radiologic evidence of mediastinal and/or hilar lymphadenopathy and a possible diagnosis of sarcoidosis.
Not a fit: Patients with previously diagnosed sarcoidosis or those who are high risk for general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing sarcoidosis, leading to better patient management.
How similar studies have performed: Other studies have shown promising results with similar biopsy techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Radiologic evidence of mediastinal and/or hilar lymphadenopathy * Attending radiologist or pulmonologist reports a possible diagnosis of sarcoidosis * Age 18 years or older Exclusion Criteria\*: These are the characteristics that a participant must NOT have in order to be eligible to participate in the study. Order Number Criteria * Severe pulmonary hypertension * Inability to undergo general anesthesia * Severe coagulopathy or bleeding diathesis * Previously diagnosed sarcoidosis * Patient presently taking clopidogrel * Patient deemed to be high risk for general anesthesia per anesthesiologist * Hemodynamic instability * Mediastinitis * Acute Hypercarbic Respiratory Failure (pCO2 \>55mmHg)
Where this trial is running
Washington, District of Columbia
- The George Washington University Hospital — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Khalil Diab, MD
- Email: kdiab@mfa.gwu.edu
- Phone: 2027412180
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.