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Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis

Primary Purpose

Sarcoidosis, Mediastinal Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
University of Calgary
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis focused on measuring Sarcoidosis, mediastinal adenopathy, bronchoscopy, Transbronchial needle aspiration, endobronchial ultrasonography

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Health Sciences Centre

Outcomes

Primary Outcome Measures

Diagnostic yield

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2006
Last Updated
September 30, 2008
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT00373555
Brief Title
Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis
Official Title
Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Mediastinal Diseases
Keywords
Sarcoidosis, mediastinal adenopathy, bronchoscopy, Transbronchial needle aspiration, endobronchial ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Primary Outcome Measure Information:
Title
Diagnostic yield
Secondary Outcome Measure Information:
Title
Sensitivity and specificity for Sarcoidosis
Title
Complication rates
Title
Length of Procedure
Title
Dose of sedation required

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Tremblay, MDCM
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19188547
Citation
Tremblay A, Stather DR, MacEachern P, Khalil M, Field SK. A randomized controlled trial of standard vs endobronchial ultrasonography-guided transbronchial needle aspiration in patients with suspected sarcoidosis. Chest. 2009 Aug;136(2):340-346. doi: 10.1378/chest.08-2768. Epub 2009 Feb 2.
Results Reference
derived

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Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis

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