Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy

Sarcoidosis, Pulmonary Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374447
• Other study ID #: NCR224078
• Status: Recruiting
• Phase: N/A
• 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
• 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lymphadenopathy
• Mediastinal Diseases
• Mediastinal Lymphadenopathy
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

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.

Locations

Country	Name	City	State
United States	The George Washington University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Yield	Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone	1 year
Secondary	Duration of Procedure	Duration of combined EBUS-TBNA +IFB procedure compared to TBNA alone	1 year
Secondary	Complications	Complications of EBUS-TBNA +IFB procedure compared to TBNA alone	1 year