Intranodal Forceps Biopsy for Sarcoidosis Diagnosis

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: Unknown

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Intranodal Forceps Biopsy for Sarcoidosis Diagnosis is an effective treatment?

The available research shows that Intranodal Forceps Biopsy (IFB) can be an effective treatment for diagnosing sarcoidosis. In a study from India, it was found that using IFB helped provide a conclusive diagnosis in 42% of patients who had negative results with another method called TBNA. This means that IFB can help avoid the need for more invasive surgical biopsies in nearly half of the cases where the initial test fails. Additionally, combining IFB with another method, EBUS-TBNA, can improve the chances of getting a correct diagnosis compared to using EBUS-TBNA alone. ^{1 2 3 4 5}

What safety data exists for EBUS-IFB in diagnosing sarcoidosis?

The safety data for EBUS-IFB, particularly in diagnosing sarcoidosis, indicates that it is a safe procedure. In a case series from India, EBUS-IFB was performed on seven patients, and no complications were reported. Additionally, EBUS-TBNA, a related procedure, has been shown to be safe with no complications in a study involving 65 patients with suspected sarcoidosis. These findings suggest that EBUS-IFB is a safe technique for obtaining tissue samples in cases where EBUS-TBNA may not provide sufficient material. ^{1 2 3 5 6}

Is intranodal forceps biopsy a promising treatment for diagnosing sarcoidosis?

Yes, intranodal forceps biopsy is a promising treatment for diagnosing sarcoidosis. It can provide more tissue for analysis, which helps in making a more accurate diagnosis, especially when other methods are not conclusive. This technique can avoid the need for more invasive surgical biopsies in many cases. ^{1 2 5 7 8}

Research Team

Mardi Gomberg, MD

Principal Investigator

The George Washington University

Eligibility Criteria

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

I am 18 years old or older.

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Combined EBUS-IFB and EBUS-TBNA vs EBUS-TBNA Alone for Intrathoracic Adenopathy: A Meta-Analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Modified Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy: A Retrospective Analysis. [2023]

3. China pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided intranodal forceps biopsy (EBUS-IFB)-technical review. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Endobronchial biopsy for sarcoidosis: a prospective study. [2019]

5. India pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound: new insight for the diagnosis of sarcoidosis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The utility of endobronchial ultrasound-transbronchial needle aspiration in patients with suspected extra-pulmonary sarcoidosis without thoracic lymphadenopathy. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Sarcoidosis--moving to the new standard of diagnosis? [2018]