Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis

This study has been completed.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00373555
First received: September 7, 2006
Last updated: September 30, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Sarcoidosis
Mediastinal Diseases
Procedure: Bronchoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Diagnostic yield

Secondary Outcome Measures:
  • Sensitivity and specificity for Sarcoidosis
  • Complication rates
  • Length of Procedure
  • Dose of sedation required

Estimated Enrollment: 50
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373555

Locations
Canada, Alberta
Health Sciences Centre
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Alain Tremblay, MDCM University of Calgary
  More Information

Additional Information:
No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alain Tremblay, University of Calgary
ClinicalTrials.gov Identifier: NCT00373555     History of Changes
Other Study ID Numbers: E-20269
Study First Received: September 7, 2006
Last Updated: September 30, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Sarcoidosis
mediastinal adenopathy
bronchoscopy
Transbronchial needle aspiration
endobronchial ultrasonography

Additional relevant MeSH terms:
Mediastinal Diseases
Sarcoidosis
Thoracic Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 11, 2014