Intranodal Forceps Biopsy for Sarcoidosis Diagnosis

Recruiting at 1 trial location

Overseen By Benjamin Delprete, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Must not be taking: Clopidogrel

Disqualifiers: Severe pulmonary hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to diagnose sarcoidosis, a condition that causes lumps of inflammatory cells in the body. Researchers compare a standard technique, EBUS-TBNA, with a newer method, EBUS-IFB (Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy), to determine which is more effective at diagnosing the condition. Participants who may be suitable have signs of swollen lymph nodes in the chest and a possible sarcoidosis diagnosis from their doctor. As an unphased trial, this study allows participants to contribute to advancing diagnostic methods for sarcoidosis.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking clopidogrel.

What prior data suggests that this biopsy method is safe for diagnosing sarcoidosis?

Research shows that endobronchial ultrasound-guided intranodal forceps biopsy (EBUS-IFB) safely collects tissue samples. This method uses ultrasound to guide forceps in taking tissue from chest lymph nodes. Studies suggest patients generally tolerate EBUS-IFB well.

Combining EBUS-IFB with EBUS-TBNA (which uses a needle) has shown promise in safely diagnosing conditions like sarcoidosis. EBUS-TBNA alone has also proven to be an accurate and safe method for confirming certain diseases. Both procedures have been used successfully and safely in previous studies, encouraging those considering joining a trial involving these techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy (EBUS-IFB) for diagnosing sarcoidosis because it offers a new approach to obtaining tissue samples. Unlike the standard Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA), which uses a needle, EBUS-IFB employs forceps to collect larger and potentially more informative samples. The hope is that this technique could improve diagnostic accuracy and reduce the need for repeat procedures, making it a promising advancement in the diagnosis of sarcoidosis.

What evidence suggests that this trial's techniques could be effective for diagnosing sarcoidosis?

Research shows that a technique called endobronchial ultrasound-guided intranodal forceps biopsy (EBUS-IFB) can diagnose sarcoidosis more effectively. In this trial, some participants will undergo EBUS-TBNA (transbronchial needle aspiration) alone, while others will receive both EBUS-TBNA and EBUS-IFB in the same procedure. Studies have found that EBUS-IFB successfully diagnoses 42% of patients not identified using the standard method, EBUS-TBNA. Combining EBUS-IFB with EBUS-TBNA improves the overall diagnostic ability. This technique allows doctors to examine lymph nodes more closely, which are small glands that can indicate sarcoidosis. Overall, EBUS-IFB shows promise in diagnosing conditions like sarcoidosis more effectively than traditional methods alone. ^{1 2 3 4 6}

Who Is on the Research Team?

Mardi Gomberg, MD

Principal Investigator

The George Washington University

Are You a Good Fit for This Trial?

This trial is for adults with suspected sarcoidosis, indicated by a specialist's report and radiologic signs of lymph node swelling in the chest. It excludes those with severe respiratory failure, pulmonary hypertension, inability to undergo anesthesia, bleeding disorders, known sarcoidosis, clopidogrel use, unstable blood pressure or heart conditions.

Inclusion Criteria

There are signs of swollen lymph nodes in the chest area on your X-rays or scans.

My lung doctor suspects I might have sarcoidosis.

Exclusion Criteria

I cannot have general anesthesia.

My blood pressure and heart rate are not stable.

I have high levels of carbon dioxide in my blood.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo EBUS-TBNA and/or EBUS-IFB procedures to assess diagnostic yield and specimen quality

1 day

1 visit (in-person)

Follow-up

Participants are monitored for complications and diagnostic outcomes after the procedure

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

Trial Overview

The study compares two biopsy methods to diagnose sarcoidosis: traditional needle aspiration (EBUS-TBNA) versus intranodal forceps biopsy (EBUS-IFB), focusing on which method more effectively confirms the diagnosis.

How Is the Trial Designed?

Group I: EBUS-TBNA + EBUS-IFB Experimental Treatment 1 Intervention

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

Group II: EBUS-TBNA Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Published Research Related to This Trial

EBUS-TBNA is an effective procedure for diagnosing mediastinal lymphadenopathy, with a notable yield of 50% for lymphomas and 80% for sarcoidosis, but sometimes requires more material for accurate diagnosis.

In a series of seven cases, the use of EBUS-intranodal forceps biopsy provided conclusive diagnoses in 42% of patients who had negative results from TBNA, with no complications reported, potentially avoiding the need for surgical biopsy in nearly half of these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided intranodal forceps biopsy (EBUS-IFB) using 19G needle tract: First case series from India. Dhamija, A., Guliani, A., Basu, AK.[2023]

Endobronchial biopsy (EBB) was found to be effective in diagnosing sarcoidosis, yielding positive results in 61.8% of patients, and significantly increased the diagnostic yield of fiberoptic bronchoscopy (FOB) by 20.6%.

The study, involving 34 patients, showed that EBB is safe, with no complications reported, and is particularly beneficial in cases with abnormal airway appearances, while still providing diagnostic tissue in 30% of patients with normal-appearing airways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial biopsy for sarcoidosis: a prospective study. Shorr, AF., Torrington, KG., Hnatiuk, OW.[2019]

Combining EBUS-guided intranodal forceps biopsy (EBUS-IFB) with EBUS-guided transbronchial needle aspiration (EBUS-TBNA) significantly increases the diagnostic yield for intrathoracic lymphadenopathy, achieving a 92% success rate compared to 67% for EBUS-TBNA alone, based on a meta-analysis of 443 patients.

While the combined approach has a higher complication rate than EBUS-TBNA alone, the overall complications (1% pneumomediastinum, 0.8% bleeding, 0.6% respiratory failure) are still lower than those associated with more invasive procedures like transbronchial or surgical biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined EBUS-IFB and EBUS-TBNA vs EBUS-TBNA Alone for Intrathoracic Adenopathy: A Meta-Analysis. Agrawal, A., Ghori, U., Chaddha, U., et al.[2022]

The modified EBUS-guided intranodal forceps biopsy (IFB) technique, which uses standard-sized forceps, demonstrated a high technical success rate of 90.8% and a diagnostic accuracy of 99.5% in a study of 195 patients with intrathoracic lymphadenopathy.

This technique resulted in minimal major complications, with only 1.0% of patients experiencing issues like pneumonia or pneumothorax, indicating it is a safe and effective method for obtaining larger histological samples compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Modified Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy: A Retrospective Analysis. Konno-Yamamoto, A., Matsumoto, Y., Imabayashi, T., et al.[2023]

Endobronchial ultrasound (EBUS) and transbronchial needle aspiration (TBNA) have significantly improved the accuracy of diagnosing lung conditions by allowing real-time visualization and sampling of mediastinal structures, although some conditions like sarcoidosis and lymphoma remain challenging to diagnose with these methods.

The introduction of EBUS-guided intranodal forceps biopsy (EBUS-IFB) offers a complementary approach for tissue acquisition, potentially enhancing the ability to obtain samples suitable for molecular testing and next-generation sequencing, which is increasingly important in targeted therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided intranodal forceps biopsy (EBUS-IFB)-technical review. Cheng, G., Mahajan, A., Oh, S., et al.[2020]

The diagnosis of sarcoidosis is reliable when there is a combination of clinical/radiological evidence and the presence of noncaseating epithelioid cell granulomas in pathology samples.

Recent advancements in diagnostic techniques, such as endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), enhance the ability to obtain necessary tissue samples for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sarcoidosis--moving to the new standard of diagnosis? Miliauskas, S., Zemaitis, M., Sakalauskas, R.[2018]

Endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) was found to be a useful diagnostic tool for extra-pulmonary sarcoidosis in patients with thoracic lymph nodes ≤10 mm and minimal pulmonary infiltrates, with a sensitivity of 75% and specificity of 100% when using bronchoscopic results as the reference standard.

In this study of 15 patients, EBUS-TBNA identified sarcoidosis in 40% of cases, suggesting it can aid in diagnosis, but further research with larger sample sizes is necessary to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of endobronchial ultrasound-transbronchial needle aspiration in patients with suspected extra-pulmonary sarcoidosis without thoracic lymphadenopathy. Aravena, C., Almeida, FA., Culver, DA., et al.[2021]

In a study of 65 patients suspected of having sarcoidosis, EBUS-TBNA successfully diagnosed the condition in 93.8% of cases, demonstrating its high diagnostic yield.

The procedure was safe, with no reported complications, and effectively identified noncaseating epithelioid cell granulomas in 91.8% of patients diagnosed with sarcoidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound: new insight for the diagnosis of sarcoidosis. Wong, M., Yasufuku, K., Nakajima, T., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6790451/

Endobronchial ultrasound-guided intranodal forceps biopsy ...

The diagnostic yield of EBUS-TBNA for sarcoidosis is lower than that for carcinoma (3,11,12). While the diagnosis of sarcoidosis can be enhanced with ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10298821/

Endobronchial ultrasound-guided intranodal forceps ...

Lymph node biopsy was able to give a conclusive diagnosis in 42% patients negative with TBNA, and was able to suggest a diagnosis in one case.

3.

ejb.springeropen.com

ejb.springeropen.com/articles/10.1186/s43168-025-00418-x

A retrospective analysis of the diagnostic utility of ...

This study aimed to evaluate the diagnostic yield of EBUS-IFB in the assessment of mediastinal lymphadenopathy.

4.

annalsthoracicsurgery.org

annalsthoracicsurgery.org/article/S0003-4975(21)00103-X/pdf

Combined EBUS-IFB and EBUS-TBNA vs ...

Overall diagnostic yield of endobronchial ultrasound–guided intranodal forceps biopsy (IFB) in combination with endobronchial ultrasound–guided transbronchial ...

5.

archbronconeumol.org

archbronconeumol.org/es-endobronchial-ultrasound-guided-intranodal-forceps-biopsy-articulo-S0300289623003770

Endobronchial Ultrasound-Guided Intranodal Forceps ...

EBUS-TBNA shows a strong overall diagnostic yield (80%) detecting mediastinal tuberculous lymphadenitis.3 It can be used for initial diagnosis of mediastinal ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022522312000888

Prospective study of endobronchial ultrasound–guided ...

Endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA) has been reported to be an accurate and safe method to confirm a pathologic ...