Clinical trial NCT05374447: Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy
Official title: Evaluating the Diagnostic Yield and Specimen Quality With Endobronchial Ultrasound-Guided Intranodal Forceps Biopsies in Patients With Mediastinal and Hilar Lymphadenopathy: A Prospective Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mediastinal Lymphadenopathy
Sarcoidosis, Pulmonary
Mediastinal Diseases
Keywords: Sarcoidosis
Bronchoscopy
Endobronchial Ultrasound
Intranodal forceps biopsy
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to EBUS-TBNA alone or EBUS-TBNA and EBUS-IFB
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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

Eligibility 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)

Primary outcomes:
measure: Diagnostic Yield
timeFrame: 1 year
Secondary outcomes:
measure: Duration of Procedure
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University Hospital
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Mardi Gomberg, MD
role: STUDY_DIRECTOR
References: