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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

Tracking Information
First Submitted Date  ICMJE April 24, 2009
First Posted Date  ICMJE April 27, 2009
Last Update Posted Date June 22, 2009
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
  • The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA) [ Time Frame: At the end of study ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
  • The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
  • The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
  • Prevalence of sarcoidosis and alternate diagnosis [ Time Frame: At the end of study ]
  • Stage distribution [ Time Frame: At the end of study ]
  • Complication rate of each type of procedure [ Time Frame: At the end of study ]
  • Cost to obtain a qualifying diagnosis with this strategy in this population [ Time Frame: At the end of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
  • Prevalence of sarcoidosis and alternate diagnosis
  • Stage distribution
  • Complication rate of each type of procedure
  • Cost to obtain a qualifying diagnosis with this strategy in this population
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis
Official Title  ICMJE Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sarcoidosis
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Procedure: Bronchoscopy
Publications * Tournoy KG, Bolly A, Aerts JG, Pierard P, De Pauw R, Leduc D, Leloup A, Pieters T, Slabbynck H, Janssens A, Carron K, Schrevens L, Pat K, De Keukeleire T, Dooms C. The value of endoscopic ultrasound after bronchoscopy to diagnose thoracic sarcoidosis. Eur Respir J. 2010 Jun;35(6):1329-35. doi: 10.1183/09031936.00111509. Epub 2009 Nov 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00888212
Other Study ID Numbers  ICMJE 2008/069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kurt Tournoy, MD, PhD, University Hospital Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kurt G. Tournoy, Md, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP