Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy

Not Applicable

Recruiting

• Conditions: Mediastinal Lymphadenopathy; Mediastinal Diseases; Sarcoidosis, Pulmonary
• Interventions: Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

• Registration Number: NCT05374447
• Lead Sponsor: George Washington University

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

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Study Start: 2022-06-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-10-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA + EBUS-IFB	Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy	These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure
EBUS-TBNA	Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy	These will be the patient who undergo EBUS-TBNA only without EBUS-IFB

Primary Outcome Measures

Name	Time	Method
Diagnostic Yield	1 year	Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone

Secondary Outcome Measures

Name	Time	Method
Complications	1 year	Complications of EBUS-TBNA +IFB procedure compared to TBNA alone
Duration of Procedure	1 year	Duration of combined EBUS-TBNA +IFB procedure compared to TBNA alone

Trial Locations

Locations (1)

The George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States