Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis

Sarcoidosis Clinical Trial

— MITOSIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888212
• Other study ID #: 2008/069
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: June 19, 2009
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)		At the end of study	No
Primary	The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy		At the end of study	No
Secondary	Prevalence of sarcoidosis and alternate diagnosis		At the end of study	No
Secondary	Stage distribution		At the end of study	No
Secondary	Complication rate of each type of procedure		At the end of study	Yes
Secondary	Cost to obtain a qualifying diagnosis with this strategy in this population		At the end of study	No

External Links

•   Website of the University Hospital Ghent