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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00888212
First received: April 24, 2009
Last updated: June 19, 2009
Last verified: June 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014