Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05374447 |
| Other study ID # |
NCR224078 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2022 |
| Est. completion date |
March 1, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
George Washington University |
| Contact |
Khalil Diab, MD |
| Phone |
2027412180 |
| Email |
kdiab[@]mfa.gwu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators will compare endobronchial ultrasound transbronchial needle aspiration
(EBUS-TBNA) with intranodal forceps biopsy (EBUS-IFB) as it relates to the rate of diagnosis
of suspected sarcoidosis.
Description:
This is prospective, single center randomized comparative study to determine the diagnostic
yield and specimen quality of endobronchial ultrasound guided intranodal forceps biopsy of
patients with suspected sarcoidosis based solely on imaging. This will be a single group
study and will compare transbronchial needle aspiration via 19 or 21-gauge needle with
intranodal forceps biopsy.
The study aims to answer a knowledge gap a as to whether the diagnostic yield and specimen
quality of EBUS-TBNA with a 19G needle is less than those obtained by 1.9mm or greater
intranodal forceps biopsy. The study proposed here will add to the field by further
elucidating whether this procedure is beneficial for the diagnosis as it pertains to
suspected sarcoidosis.
The anticipated required enrollment is 55 patients to achieve an α of 0.05 and β of 0.2. This
assumes an unassisted diagnostic yield of 62.5% with standard of care EBUS-TBNA as reported
in Ray et al, and a diagnostic supplementation to 80% yield with intranodal forceps biopsies.
References
1. Oki, M., Saka, H., & Sako, C. (2004). Bronchoscopic miniforceps biopsy for mediastinal
nodes. Journal of Bronchology & Interventional Pulmonology, 11(3), 150-153.
2. Herth FJ, Morgan RK, Eberhardt R, Ernst A. Endobronchial ultrasound-guided miniforceps
biopsy in the biopsy of subcarinal masses in patients with low likelihood of non-small
cell lung cancer. Ann Thorac Surg. 2008 Jun; 85(6):1874-8.
3. Chrissian A, Misselhorn D, Chen A. Endobronchial-ultrasound guided miniforceps biopsy of
mediastinal and hilar lesions. The Annals of Thoracic Surgery. 2011;92(1):284-288.
4. Franke KJ, Bruckner C, Szyrach M, Ruhle KH, Nilius G, Theegarten D. The contribution of
endobronchial ultrasound-guided forceps biopsy in the diagnostic workup of unexplained
mediastinal and hilar lymphadenopathy. Lung. 2012;190(2):227-232.
5. Herth FJF, Schuler H, Gompelmann D, et al. Endobronchial ultrasound-guided lymph node
biopsy with transbronchial needle forceps: a pilot study. European Respiratory Journal.
2012;39(2):373-377.
6. Darwiche K, Freitag L, Nair A, et al. Evaluation of a novel endobronchial
ultrasound-guided lymph node forceps in enlarged mediastinal lymph nodes. Respiration.
2013;86(3):229-236.
7. Ray AS, Li C, Murphy TE, et al. Improved diagnostic yield and specimen quality with
endobronchial ultrasound-guided forceps biopsies: a retrospective analysis. The Annals
of Thoracic Surgery. 2020;109(3):894-901
