search
Back to results

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

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bronchoscopy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2009
Last Updated
June 19, 2009
Sponsor
University Hospital, Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT00888212
Brief Title
Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis
Acronym
MITOSIS
Official Title
Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchoscopy
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
Time Frame
At the end of study
Title
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 Measure Information:
Title
Prevalence of sarcoidosis and alternate diagnosis
Time Frame
At the end of study
Title
Stage distribution
Time Frame
At the end of study
Title
Complication rate of each type of procedure
Time Frame
At the end of study
Title
Cost to obtain a qualifying diagnosis with this strategy in this population
Time Frame
At the end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt G. Tournoy, Md, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV Ziekenhuis Aalst
City
Aalst
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerp
Country
Belgium
Facility Name
ZNA Antwerpen
City
Antwerp
Country
Belgium
Facility Name
AZ St. Jan Hospitaal Brugge
City
Brugge
Country
Belgium
Facility Name
Cliniques Universitaires St. Luc
City
Brussels
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
Country
Belgium
Facility Name
Höpital Erasme Brussel
City
Brussel
Country
Belgium
Facility Name
CHU Charleroi
City
Charleroi
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Virga Jesse Hospitaal
City
Hasselt
Country
Belgium
Facility Name
UZ Gasthuisberg Leuven
City
Leuven
Country
Belgium
Facility Name
Heilig Hartziekenhuis Menen
City
Menen
Country
Belgium
Facility Name
Hôpital Saint Elisabeth Namur
City
Namur
Country
Belgium
Facility Name
AZ Oudenaarde
City
Oudenaarde
Country
Belgium
Facility Name
Ampha Ziekenhuis Breda
City
Breda
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19897553
Citation
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.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis

We'll reach out to this number within 24 hrs