Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy

NCT05374447 | Completed DMC

• 1 other identifier: NCR224078
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediastinal Lymphadenopathy; Sarcoidosis, Pulmonary; Mediastinal Diseases

Keywords

Sarcoidosis; Bronchoscopy; Endobronchial Ultrasound; Intranodal forceps biopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone

  1 year

Secondary Outcomes (2)

• Duration of Procedure

  1 year

• Complications

  1 year

Study Arms (2)

EBUS-TBNA

ACTIVE COMPARATOR

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

Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

EBUS-TBNA + EBUS-IFB

EXPERIMENTAL

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

Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

Interventions

Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy 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.

Also known as: EBUS-IFB

EBUS-TBNA; EBUS-TBNA + EBUS-IFB

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiologic evidence of mediastinal and/or hilar lymphadenopathy
• Attending radiologist or pulmonologist reports a possible diagnosis of sarcoidosis
• Age 18 years or older

You may not qualify if:

• 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)

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Mediastinal Diseases; Sarcoidosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Thoracic Diseases

Study Officials

• Mardi Gomberg, MD

  The George Washington University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be blinded to which group they were randomized to.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD - Associate Professor

Model Details: 1:1 randomization to EBUS-TBNA alone or EBUS-TBNA and EBUS-IFB

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: June 10, 2022
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)