Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis

NCT00373555 | Completed

• 1 other identifier: E-20269
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis; Mediastinal Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

Secondary Outcomes (4)

• Sensitivity and specificity for Sarcoidosis

• Complication rates

• Length of Procedure

• Dose of sedation required

Interventions

Bronchoscopy PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Health Sciences Centre

Calgary, Alberta, T2N 4N1, Canada

Location

Related Publications (1)

• 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.

  PMID: 19188547 DERIVED

MeSH Terms

Conditions

Sarcoidosis; Mediastinal Diseases

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Thoracic Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Alain Tremblay, MDCM

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: August 1, 2008
• Last Updated: October 2, 2008

Record last verified: 2008-08

Locations

CA (1)