Mediastinal LymphadenopathyNCT05374447
Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy
A study testing Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy in people with Mediastinal Lymphadenopathy and Sarcoidosis, Pulmonary, run by George Washington University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mediastinal Lymphadenopathy, Sarcoidosis, Pulmonary, Mediastinal Diseases
- What is being tested?
- Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologic evidence of mediastinal and/or hilar lymphadenopathy
- Attending radiologist or pulmonologist reports a possible diagnosis of sarcoidosis
- Age 18 years or older
Who cannot join
- 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
Show all 11Show fewer
- Patient presently taking clopidogrel
- Patient deemed to be high risk for general anesthesia per anesthesiologist
- Hemodynamic instability
- Mediastinitis
- Acute Hypercarbic Respiratory Failure (pCO2 >55mmHg)
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
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
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.
Read the 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
- Oki, M., Saka, H., \& Sako, C. (2004). Bronchoscopic miniforceps biopsy for mediastinal nodes. Journal of Bronchology \& Interventional Pulmonology, 11(3), 150-153.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Being tested
- Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy
- Keywords
- Sarcoidosis, Bronchoscopy, Endobronchial Ultrasound, Intranodal forceps biopsy
- Medical subject headings
- Sarcoidosis, Pulmonary, Mediastinal Diseases, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial Ultrasound-Guided Intranodal Forceps BiopsyProcedure or surgery
Also called EBUS-IFB
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.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA | Active comparator | These will be the patient who undergo EBUS-TBNA only without EBUS-IFB Receives: 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 Receives: Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone
Measured: 1 year
Secondary outcomes (2)
Duration of Procedure
Duration of combined EBUS-TBNA +IFB procedure compared to TBNA alone
Measured: 1 year
Complications
Complications of EBUS-TBNA +IFB procedure compared to TBNA alone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start10 Jun 2022
- Primary completion11 Feb 2025
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal LymphadenopathyStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to EBUS-TBNA alone or EBUS-TBNA and EBUS-IFB
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalil Diab, George Washington University
- Investigators
- Mardi Gomberg, MD, Study director, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374447
- Sponsor's protocol ID
- NCR224078
- Status last verified
- Apr 2026
- First submitted
- 10 May 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05374447
- Acronym / sponsor ID
- NCR224078
- Keywords
- Sarcoidosis, Bronchoscopy, Endobronchial Ultrasound, Intranodal forceps biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Oki, M., Saka, H., \& Sako, C. (2004). Bronchoscopic miniforceps biopsy for mediastinal nodes. Journal of Bronchology \& Interventional Pulmonology, 11(3), 150-153.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1:1 randomization to EBUS-TBNA alone or EBUS-TBNA and EBUS-IFB
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA | Active comparator | Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps BiopsyThese will be the patient who undergo EBUS-TBNA only without EBUS-IFB |
| EBUS-TBNA + EBUS-IFB | Experimental | Procedure: Endobronchial Ultrasound-Guided Intranodal Forceps BiopsyThese will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiologic evidence of mediastinal and/or hilar lymphadenopathy
- Attending radiologist or pulmonologist reports a possible diagnosis of sarcoidosis
- Age 18 years or older
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial Ultrasound-Guided Intranodal Forceps BiopsyAlso: EBUS-IFBPatients 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. | Procedure or surgery | EBUS-TBNA, EBUS-TBNA + EBUS-IFB |
Primary outcome
Diagnostic Yield
Time frame: 1 year
Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone
2 secondary outcomes
Duration of Procedure
Time frame: 1 year
Complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mardi Gomberg, MD study director
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy in people with Mediastinal Lymphadenopathy and Sarcoidosis, Pulmonary, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.