Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis
• Interventions: Procedure: Bronchoscopy

• Registration Number: NCT00888212
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-19
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bronchoscopy	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Virga Jesse Hospitaal; 🇧🇪 Hasselt, Belgium

UZ Gasthuisberg Leuven; 🇧🇪 Leuven, Belgium

Heilig Hartziekenhuis Menen; 🇧🇪 Menen, Belgium

Hôpital Saint Elisabeth Namur; 🇧🇪 Namur, Belgium

ZNA Antwerpen; 🇧🇪 Antwerp, Belgium

OLV Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerp, Belgium

Höpital Erasme Brussel; 🇧🇪 Brussel, Belgium

AZ St. Jan Hospitaal Brugge; 🇧🇪 Brugge, Belgium

University Hospital Brussels; 🇧🇪 Brussels, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Cliniques Universitaires St. Luc; 🇧🇪 Brussels, Belgium

CHU Charleroi; 🇧🇪 Charleroi, Belgium

AZ Oudenaarde; 🇧🇪 Oudenaarde, Belgium

Ampha Ziekenhuis Breda; 🇳🇱 Breda, Netherlands