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Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS)

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ClinicalTrials.gov Identifier: NCT00888212
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : June 22, 2009
Sponsor:
Information provided by:
University Hospital, Ghent

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Sarcoidosis Procedure: Bronchoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)
Study Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA) [ Time Frame: At the end of study ]
  2. 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 ]

Secondary Outcome Measures :
  1. Prevalence of sarcoidosis and alternate diagnosis [ Time Frame: At the end of study ]
  2. Stage distribution [ Time Frame: At the end of study ]
  3. Complication rate of each type of procedure [ Time Frame: At the end of study ]
  4. Cost to obtain a qualifying diagnosis with this strategy in this population [ Time Frame: At the end of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888212


Locations
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Belgium
OLV Ziekenhuis Aalst
Aalst, Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
ZNA Antwerpen
Antwerp, Belgium
AZ St. Jan Hospitaal Brugge
Brugge, Belgium
Cliniques Universitaires St. Luc
Brussels, Belgium
University Hospital Brussels
Brussels, Belgium
Höpital Erasme Brussel
Brussel, 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
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Principal Investigator: Kurt G. Tournoy, Md, PhD University Hospital, Ghent
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kurt Tournoy, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00888212    
Other Study ID Numbers: 2008/069
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases