Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy

Evaluating the Diagnostic Yield and Specimen Quality With Endobronchial Ultrasound-Guided Intranodal Forceps Biopsies in Patients With Mediastinal and Hilar Lymphadenopathy: A Prospective Analysis

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.

Study Overview

• Status: Completed
• Conditions: Sarcoidosis, Pulmonary; Mediastinal Lymphadenopathy; Mediastinal Diseases
• Intervention / Treatment: Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • The George Washington University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EBUS-TBNA; These will be the patient who undergo EBUS-TBNA only without EBUS-IFB	Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy; Patients with mediastinal adenopathy will undergo EBUS-IFB and EBUS-TBNA during the same procedure to compare the yield of this procedure with EBUS-TBNA alone.; Other Names: EBUS-IFB
Experimental: EBUS-TBNA + EBUS-IFB; These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure	Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy; Patients with mediastinal adenopathy will undergo EBUS-IFB and EBUS-TBNA during the same procedure to compare the yield of this procedure with EBUS-TBNA alone.; Other Names: EBUS-IFB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield	Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Procedure	Duration of combined EBUS-TBNA +IFB procedure compared to TBNA alone	1 year
Complications	Complications of EBUS-TBNA +IFB procedure compared to TBNA alone	1 year

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Study Director: Mardi Gomberg, MD, The George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2026

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Bronchoscopy; Sarcoidosis; Endobronchial Ultrasound; Intranodal forceps biopsy
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Lung Diseases, Interstitial; Hypersensitivity, Delayed; Thoracic Diseases; Hemic and Lymphatic Diseases; Sarcoidosis, Pulmonary; Sarcoidosis; Mediastinal Diseases
• Other Study ID Numbers: NCR224078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No