Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00872612
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2009-03-30
Brief Title:
Trial for the Diagnosis of Sarcoidosis
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Endosonography EUS and EBUS vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRANULOMA
Brief Summary:
This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage III
The objective is to assess the role of endosonography EBUS EUS - FNA in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy TBLB EBB
Also the researchers investigate the additional value of BAL in relation to endosonography and conventional bronchoscopy TBLB EBB in diagnosing sarcoidosis
Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup
The objective is to assess the role of endosonography EBUS EUS - FNA in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy TBLB EBB
Also the researchers investigate the additional value of BAL in relation to endosonography and conventional bronchoscopy TBLB EBB in diagnosing sarcoidosis
Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup
Detailed Description:
Sarcoidosis is the most prevalent interstitial lung disease in Western-Europe and the US The disease is most prevalent in young adults To set the final diagnosis of sarcoidosis the following parameters need to be present
1 A clinical and radiological suspicion of sarcoidosis stage III
2 A tissue diagnosis of disease-specific non-caseating granulomas
3 Exclusion of possible alternative diagnoses as lung cancer or tuberculosis
Nowadays a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis However these biopsies are only diagnostic in 70 of the procedures and they are associated with a 3 risk of coughing up blood and a 4 risk of a lung collapse
Since recently a new diagnostic procedure has come available This procedure endo-sonography makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85 The associated risk of complications appears to be small 1
We consider the current standard for the diagnostics of sarcoidosis to be outdated considering the clinical availability of endo-sonography We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis
Also we hypothesize that this technique is safer and more preferred by patients
1 A clinical and radiological suspicion of sarcoidosis stage III
2 A tissue diagnosis of disease-specific non-caseating granulomas
3 Exclusion of possible alternative diagnoses as lung cancer or tuberculosis
Nowadays a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis However these biopsies are only diagnostic in 70 of the procedures and they are associated with a 3 risk of coughing up blood and a 4 risk of a lung collapse
Since recently a new diagnostic procedure has come available This procedure endo-sonography makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85 The associated risk of complications appears to be small 1
We consider the current standard for the diagnostics of sarcoidosis to be outdated considering the clinical availability of endo-sonography We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis
Also we hypothesize that this technique is safer and more preferred by patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None