Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy for Sarcoidosis

1
Effectiveness
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Safety
The George Washington University Hospital, Washington, United States
+4 More
Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy

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Eligible Conditions

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

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy will improve 1 primary outcome and 2 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of 1 year.

1 year
Complications
Diagnostic Yield
Duration of Procedure

Trial Safety

Trial Design

2 Treatment Groups

EBUS-TBNA
EBUS-TBNA + EBUS-IFB

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

EBUS-TBNA + EBUS-IFB
Procedure
These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure
EBUS-TBNA
Procedure
These will be the patient who undergo EBUS-TBNA only without EBUS-IFB

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Who is running the study

Principal Investigator
K. D.
Prof. Khalil Diab, MD - Associate Professor
George Washington University

Closest Location

The George Washington University Hospital - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must be between the ages of 18 and 35 years old. show original
You have radiologic evidence of mediastinal and/or hilar lymphadenopathy. show original
You are attending a radiologist or pulmonologist report a possible diagnosis of sarcoidosis. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lymphadenopathy?

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Lymphadenopathy is an enlargement of lymph nodes and/or tissues in the body containing lymph. Lymph-laden tissues are often a result of infection. Some lymph-laden tissues are a result of cancers of the lymph nodes or surrounding tissues. However, lymph node disorders are most often a result of a malfunction in the lymph nodes. Although many types of lymphadenopathy occur in humans, there are only three categories in this article. These three categories are enlarged lymph nodes, enlarged lymph nodes that are not swollen, and enlarged lymph nodes that are swollen to some degree.

Unverified Answer

Can lymphadenopathy be cured?

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Lymphadenopathy, although a very prominent symptom, is, by definition, a benign and self-limiting condition. Lymphadenopathy is not a life-threatening disorder and the patient can proceed to standard follow-up management.

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How many people get lymphadenopathy a year in the United States?

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Each year approximately 4.9 million men and 1.75 million women develop some type of lymphadenopathy and, in general, lymphatic disorders are more common in men than women. A high rate of lymphadenopathy is prevalent in both patients with inflammatory diseases and those with rheumatoid diseases, and is a significant cause of morbidity in patients with rheumatoid diseases.

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What are common treatments for lymphadenopathy?

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Gastrointestinal complaints may result from noncancer disorders such as irritable bowel syndrome, ulcerative colitis and diverticulosis. When a cancer is suspected, an upper GI series is performed, with a CT esophagogastroduodenoscopy performed if a tumor is found. A biopsy may be used to diagnose cancer, but often needs further evaluation by a pathologist.

Unverified Answer

What causes lymphadenopathy?

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Lymphadenopathy in patients with HIV and cryptococcal meningitis and in patients with sarcoidosis has been linked to specific infections including mycobacterium (mycobacterium africanum and mycobacterium leprae), mycobacterium xenopicum, cryptococcus, and staphylococcus. These pathogens produce cytokines that cause a breakdown of the endothelium in a lymphatic capillary where lymph cells can accumulate. Most patients with lymphadenopathy will have no known cause.

Unverified Answer

What are the signs of lymphadenopathy?

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A systematic examination of superficial lymph nodes is required for accurate diagnosis of lymphadenopathy. The presence of enlarged peripheral lymph nodes without peripheral adenopathy suggests lymphoma rather than noninfectious causes of lymphadenopathy such as inflammatory breast cancer.

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How serious can lymphadenopathy be?

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Patients with Lymphadenopathy often have other serious disorders. So, a correct diagnosis is important before starting treatment for Lymphadenopathy. However, atypical lymphadenopathy is common and has varied underlying diagnoses, which will determine whether to treat or just observe it.

Unverified Answer

Is endobronchial ultrasound-guided intranodal forceps biopsy typically used in combination with any other treatments?

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This is the first study to report the use of EUS-guided forceps biopsy in combination with any other treatment for malignant hilar and mediastinal lesions.

Unverified Answer

What are the latest developments in endobronchial ultrasound-guided intranodal forceps biopsy for therapeutic use?

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Endoscopic ultrasonography-guided endobronchial ultrasound forceps biopsy is safe, with a higher overall success rate while the complication rate is acceptable. Results from a recent clinical trial have potential to simplify indications for therapeutic EUS-FNB and in helping physicians to reduce the overall cost of EUS-FNB.

Unverified Answer

Have there been other clinical trials involving endobronchial ultrasound-guided intranodal forceps biopsy?

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The current clinical trial using EBUS-FNA was only reported for the first time in the literature. Further research is needed to establish the use of these new technology as a clinical diagnostic tool for lung cancer.

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What is the average age someone gets lymphadenopathy?

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The average age at which most individuals get lymphadenopathy seems to be around 30 years old. The increase in incidence is not attributed to a change in prevalence of lymphadenopathy in the general population.

Unverified Answer

How does endobronchial ultrasound-guided intranodal forceps biopsy work?

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Endobronchial ultrasound-guided intranodal forceps biopsy appears superior to transthoracic needle biopsy for the diagnosis of unsuspected malignancy. In a recent study, findings suggest that endobronchial ultrasound-guided intranodal forceps biopsy should be considered the preferred method of sample acquisition in this setting, regardless of the operator's level of experience.

Unverified Answer
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