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

University Hospital, Ghent15 sites in 2 countries100 target enrollmentJune 2008

ConditionsSarcoidosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sarcoidosis
Sponsor: University Hospital, Ghent
Enrollment: 100
Locations: 15
Primary Endpoint: The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

June 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Ghent

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)