Clinical trial NCT00888212: Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis
Official title: Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
timeFrame: At the end of study
measure: The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy
timeFrame: At the end of study
Secondary outcomes:
measure: Prevalence of sarcoidosis and alternate diagnosis
timeFrame: At the end of study
measure: Stage distribution
timeFrame: At the end of study
measure: Complication rate of each type of procedure
timeFrame: At the end of study
measure: Cost to obtain a qualifying diagnosis with this strategy in this population
timeFrame: At the end of study
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Antwerp
country: Belgium
facility: ZNA Antwerpen
city: Brugge
country: Belgium
facility: AZ St. Jan Hospitaal Brugge
city: Brussels
country: Belgium
facility: Cliniques Universitaires St. Luc
city: Brussels
country: Belgium
facility: University Hospital Brussels
city: Brussel
country: Belgium
facility: Höpital Erasme Brussel
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Hasselt
country: Belgium
facility: Virga Jesse Hospitaal
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
city: Menen
country: Belgium
facility: Heilig Hartziekenhuis Menen
city: Namur
country: Belgium
facility: Hôpital Saint Elisabeth Namur
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
city: Breda
country: Netherlands
facility: Ampha Ziekenhuis Breda
Study officials:
affiliation: University Hospital, Ghent
name: Kurt G. Tournoy, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.