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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcoidosis
• Intervention / Treatment: Procedure: Bronchoscopy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV Ziekenhuis Aalst
  • Antwerp, Belgium
    • ZNA Antwerpen
  • Antwerp, Belgium
    • Universitair Ziekenhuis Antwerpen
  • Brugge, Belgium
    • AZ St. Jan Hospitaal Brugge
  • Brussel, Belgium
    • Höpital Erasme Brussel
  • Brussels, Belgium
    • University Hospital Brussels
  • Brussels, Belgium
    • Cliniques Universitaires St. Luc
  • Charleroi, Belgium
    • Chu Charleroi
  • Ghent, Belgium, 9000
    • University Hospital Ghent
  • Hasselt, Belgium
    • Virga Jesse Hospitaal
  • Leuven, Belgium
    • UZ Gasthuisberg Leuven
  • Menen, Belgium
    • Heilig Hartziekenhuis Menen
  • Namur, Belgium
    • Hôpital Saint Elisabeth Namur
  • Oudenaarde, Belgium
    • AZ Oudenaarde
• Netherlands
  • Breda, Netherlands
    • Ampha Ziekenhuis Breda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)	At the end of study
The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy	At the end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence of sarcoidosis and alternate diagnosis	At the end of study
Stage distribution	At the end of study
Complication rate of each type of procedure	At the end of study
Cost to obtain a qualifying diagnosis with this strategy in this population	At the end of study

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Kurt G. Tournoy, Md, PhD, University Hospital, Ghent

Publications and helpful links

General 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.

Helpful Links

• Website of the University Hospital Ghent

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 24, 2009
• First Submitted That Met QC Criteria: April 24, 2009
• First Posted (Estimate): April 27, 2009

Study Record Updates

• Last Update Posted (Estimate): June 22, 2009
• Last Update Submitted That Met QC Criteria: June 19, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• Other Study ID Numbers: 2008/069