Trial for the Diagnosis of Sarcoidosis

Phase 3

Completed

• Conditions: Sarcoidosis
• Interventions: Procedure: EBB + TBLB + BAL; Procedure: EUS-FNA/EBUS-TBNA + BAL

• Registration Number: NCT00872612
• Lead Sponsor: Leiden University Medical Center

Brief Summary

This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II.

The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).

Also the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.

Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.

Detailed Description

Sarcoidosis is the most prevalent interstitial lung disease in Western-Europe and the US. The disease is most prevalent in young adults. To set the final diagnosis of sarcoidosis, the following parameters need to be present:

1. A clinical and radiological suspicion of sarcoidosis stage I/II.

2. A tissue diagnosis of disease-specific non-caseating granulomas.

3. Exclusion of possible alternative diagnoses as lung cancer or tuberculosis.

Nowadays, a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis. However, these biopsies are only diagnostic in 70% of the procedures and they are associated with a 3% risk of coughing up blood and a 4% risk of a lung collapse.

Since recently, a new diagnostic procedure has come available. This procedure, endo-sonography, makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85%. The associated risk of complications appears to be small (\<1%)

We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography. We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis.

Also we hypothesize that this technique is safer and more preferred by patients.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Primary Completion: 2011-11
• Study Completion: 2012-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• Patients with suspected pulmonary sarcoidosis stage I/ II
• Age > 18 years
• Both males and females
• Written informed consent is obtained.

Exclusion Criteria

• Patients with obvious other organ involvement of sarcoidosis where a simple diagnostic biopsy to assess granulomas can be performed.
• Löfgren's syndrome
• Inability to undergo fiberbronchoscopy, EBUS or EUS (e.g. respiratory insufficiency, esophageal stenosis
• Contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia)
• Pregnancy
• Inability to obtain informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	EBB + TBLB + BAL	Conventional bronchoscopy arm
A	EUS-FNA/EBUS-TBNA + BAL	Endosonography arm

Primary Outcome Measures

Name	Time	Method
The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB)	within a week

Secondary Outcome Measures

Name	Time	Method
The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis	2 weeks
Assessment of complications of both the endosonography and conventional bronchoscopic workup	within 30 days
Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up.	within a week

Trial Locations

Locations (15)

St. Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

St. Franciscus Ziekenhuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

University hospital Krakow, J.P. II; 🇵🇱 Krakow, Poland

Medisch Centrum Haaglanden; 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Gentofte Hospital Copenhagen; 🇩🇰 Hellerup, Copenhagen, Denmark

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Pulmonary Department, Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Rijnstaete Ziekenhuis; 🇳🇱 Arnhem, Gelderland, Netherlands

Hospital Grosshansdorf; 🇩🇪 Grosshansdorf, Schleswig-Holstein, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Chelsea and Westminster hospital; 🇬🇧 London, United Kingdom

Sokołowski Pulmonary Hospital; 🇵🇱 Zakopane, Poland

Radboud Universitair Medisch Centrum; 🇳🇱 Nijmegen, Gelderland, Netherlands

Royal Brompton Hospital; 🇬🇧 London, United Kingdom