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Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis

Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00373555
Enrollment
50
Registered
2006-09-08
Start date
2006-09-30
Completion date
2008-08-31
Last updated
2008-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mediastinal Diseases, Sarcoidosis

Keywords

Sarcoidosis, mediastinal adenopathy, bronchoscopy, Transbronchial needle aspiration, endobronchial ultrasonography

Brief summary

Sarcoidosis is a benign, inflammatory condition which will typically involve the lungs and lymph glands in the chest. Diagnosis is often confirmed with bronchoscopic biopsy. A new method of performing bronchoscopic biopsy of lymph glands in the chest has now been developed which uses real-time endobronchial ultrasonography to better locate the lymph glands. While this technique has been proven to be effective in the diagnosis and staging of lung malignancy, its sensitivity for the diagnosis of sarcoidosis is unclear as smaller samples are obtained compared to the standard approach. This study will aim to randomize 50 patients with a clinical suspicion of sarcoidosis to standard biopsy vs. endobronchial ultrasound guided biopsy of the mediastinal lymph glands in order to compare the sensitivity of these tests for sarcoidosis.

Detailed description

Sarcoidosis is a benign, inflammatory condition which will typically involve the lungs and mediastinal lymph nodes. The diagnosis of sarcoidosis is usually confirmed with tissue biopsy, especially if patients in whom treatment with corticosteroids is required. Asymptomatic patients not requiring treatment may not require biopsy, although this is commonly performed because of patient's preference in confirming the diagnosis and concerns about other diagnostic possibilities such as lymphoma. Given the predilection of this disease to the chest, the lung and mediastinal lymph nodes are the most common sites for biopsy. Bronchoscopic samples are often obtained initially given their good sensitivity for this disease and low complication rates. If the diagnosis of sarcoidosis is not confirmed by bronchoscopy, more invasive surgical procedures such as mediastinoscopy or open lung biopsy may be required. As such, any improvement in the minimally invasive methods for diagnosis of this condition would be of benefit these patients and may also lead to cost efficiencies for the health care system. Transbronchial needle aspiration (TBNA) with a 19 gauge histology needle has been the standard bronchoscopic approach to the biopsy of mediastinal lymph nodes in patients with suspected sarcoidosis. Using anatomical landmarks and computed tomography (CT) images, the TBNA needle is advanced blindly through the airway wall, and into the mediastinal lymph node. Because of the lack of real-time visual guidance, it is possible to miss the targeted lymph node as well as enter vascular structures with the needle system and cause bleeding. A new method of performing TBNA has now been developed which uses real-time endobronchial ultrasonography to advance a 22 gauge needle into mediastinal lymph nodes under direct visualization (EBUS-TBNA). While this technique has been proven to be effective in the diagnosis and staging of lung malignancy, its sensitivity for the diagnosis of sarcoidosis is unclear given that larger biopsy samples are often required to make this diagnosis. This study will aim to randomize patients with a clinical suspicion of sarcoidosis and mediastinal adenopathy undergoing bronchoscopy to TBNA vs. EBUS-TBNA in order to compare the sensitivity of these tests for sarcoidosis.

Interventions

PROCEDUREBronchoscopy

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age over 16 years * pathological mediastinal or hilar adenopathy (over 1 cm short axis) confirmed on Computed Tomography (CT) of the chest * clinical/radiological diagnosis of sarcoidosis is considered likely diagnosis * clinical decision made by patient and treating physician to proceed to bronchoscopy

Exclusion criteria

* absence of informed consent * uncorrected coagulopathy * platelets under 100 * INR over 1.3 * use of clopidogrel in the 7 days prior to bronchoscopy * medical contraindication to bronchoscopy

Design outcomes

Primary

MeasureTime frame
Diagnostic yield

Secondary

MeasureTime frame
Sensitivity and specificity for Sarcoidosis
Complication rates
Length of Procedure
Dose of sedation required

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026