Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS)
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00888212
First received: April 24, 2009
Last updated: June 19, 2009
Last verified: June 2009
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Purpose
The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.
| Condition | Intervention |
|---|---|
|
Sarcoidosis |
Procedure: Bronchoscopy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA) [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
- The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Prevalence of sarcoidosis and alternate diagnosis [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
- Stage distribution [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
- Complication rate of each type of procedure [ Time Frame: At the end of study ] [ Designated as safety issue: Yes ]
- Cost to obtain a qualifying diagnosis with this strategy in this population [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bronchoscopy
Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy
|
Procedure: Bronchoscopy
Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 y
- Suspicion of thoracic sarcoidosis and need for tissue confirmation
- Recent (<6 weeks) RX and CT-thorax (HRCT not compulsory)
- Fit for bronchoscopy (with or without EBB, TBB, TBNA), esophagoscopy and surgery
- Written informed consent
Exclusion Criteria:
- Patients with obvious other organ involvement allowing "simple and safe" biopsy
- Lofgren syndrome
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888212
Locations
| Belgium | |
| OLV Ziekenhuis Aalst | |
| Aalst, Belgium | |
| Universitair Ziekenhuis Antwerpen | |
| Antwerp, Belgium | |
| ZNA Antwerpen | |
| Antwerp, Belgium | |
| AZ St. Jan Hospitaal Brugge | |
| Brugge, Belgium | |
| Höpital Erasme Brussel | |
| Brussel, Belgium | |
| University Hospital Brussels | |
| Brussels, Belgium | |
| Cliniques Universitaires St. Luc | |
| Brussels, Belgium | |
| CHU Charleroi | |
| Charleroi, Belgium | |
| University Hospital Ghent | |
| Ghent, Belgium, 9000 | |
| Virga Jesse Hospitaal | |
| Hasselt, Belgium | |
| UZ Gasthuisberg Leuven | |
| Leuven, Belgium | |
| Heilig Hartziekenhuis Menen | |
| Menen, Belgium | |
| Hôpital Saint Elisabeth Namur | |
| Namur, Belgium | |
| AZ Oudenaarde | |
| Oudenaarde, Belgium | |
| Netherlands | |
| Ampha Ziekenhuis Breda | |
| Breda, Netherlands | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Kurt G. Tournoy, Md, PhD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided by University Hospital, Ghent
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kurt Tournoy, MD, PhD, University Hospital Ghent |
| ClinicalTrials.gov Identifier: | NCT00888212 History of Changes |
| Other Study ID Numbers: | 2008/069 |
| Study First Received: | April 24, 2009 |
| Last Updated: | June 19, 2009 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013