SarcoidosisNCT00373555
Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis
A study testing Bronchoscopy in people with Sarcoidosis and Mediastinal Diseases, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoidosis, Mediastinal Diseases
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sarcoidosis, Mediastinal Diseases
- Being tested
- Bronchoscopy
- Keywords
- Sarcoidosis, mediastinal adenopathy, bronchoscopy, Transbronchial needle aspiration, endobronchial ultrasonography
- Medical subject headings
- Sarcoidosis, Mediastinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Secondary outcomes (4)
Sensitivity and specificity for Sarcoidosis
Complication rates
Length of Procedure
Dose of sedation required
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Alain Tremblay, MDCM, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373555
- Sponsor's protocol ID
- E-20269
- Status last verified
- Aug 2008
- First submitted
- 7 Sep 2006
- Last updated
- 2 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19188547
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis
- ClinicalTrials.gov ID
- NCT00373555
- Acronym / sponsor ID
- E-20269
- Conditions
- Sarcoidosis, Mediastinal Diseases
- Keywords
- Sarcoidosis, mediastinal adenopathy, bronchoscopy, Transbronchial needle aspiration, endobronchial ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- absence of informed consent
- uncorrected coagulopathy
- platelets under 100
- INR over 1.3
- use of clopidogrel in the 7 days prior to bronchoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy | Procedure or surgery | – |
Primary outcome
Diagnostic yield
4 secondary outcomes
Sensitivity and specificity for Sarcoidosis
Complication rates
Length of Procedure
Dose of sedation required
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2008.
- Derived from this study: PubMed 19188547Tremblay 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.
- Investigator home pageLink provided by the sponsor.
Related trials for Sarcoidosis
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Tremblay, MDCM principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Sarcoidosis and Mediastinal Diseases, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2008.