Sarcoidosis
Conditions
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.
Interventions
PROCEDUREBronchoscopy
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
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
Belgium, Netherlands
Outcome results
None listed