Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy

NCT ID: NCT05374447

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2026-03-01

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

Conditions

Mediastinal Lymphadenopathy; Sarcoidosis, Pulmonary; Mediastinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

EBUS-TBNA

These will be the patient who undergo EBUS-TBNA only without EBUS-IFB

Group Type: ACTIVE_COMPARATOR

Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

Intervention Type: PROCEDURE

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.

EBUS-TBNA + EBUS-IFB

These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure

Group Type: EXPERIMENTAL

Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

EBUS-IFB

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Khalil Diab

MD - Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mardi Gomberg, MD

Role: STUDY_DIRECTOR

The George Washington University

Locations

The George Washington University Hospital

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Khalil Diab, MD

Role: CONTACT

kdiab@mfa.gwu.edu

2027412180

Benjamin Delprete, DO

Role: CONTACT

bdelprete@mfa.gwu.edu

2027412180

Facility Contacts

Khalil Diab, MD

Role: primary

kdiab@mfa.gwu.edu

2027412180

Benjamin Delprete, DO

Role: backup

bdelprete@mfa.gwu.edu

2027412180

Other Identifiers

NCR224078

Identifier Type: -

Identifier Source: org_study_id