Trial for the Diagnosis of Sarcoidosis

Sarcoidosis Clinical Trial

— GRANULOMA  

Official title:

Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872612
• Other study ID #: LUMC-GRANULOMA
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2009
• Last updated: December 4, 2015
• Start date: March 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2015
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Procedure:
• EUS-FNA/EBUS-TBNA + BAL
EUS-FNA = Endoscopic Ultrasound guided fine needle aspiration of mediastinal lymph nodes. EBUS-TBNA = Endobronchial Ultrasound guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. BAL = bronchoalveolar lavage
• EBB + TBLB + BAL
EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Gent
Denmark	Gentofte Hospital Copenhagen	Hellerup	Copenhagen
Germany	Hospital Grosshansdorf	Grosshansdorf	Schleswig-Holstein
Germany	Thoraxklinik Heidelberg	Heidelberg	Baden-Württemberg
Netherlands	Rijnstaete Ziekenhuis	Arnhem	Gelderland
Netherlands	Medisch Centrum Haaglanden	Den Haag	Zuid-Holland
Netherlands	St. Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Netherlands	Pulmonary Department, Leiden University Medical Center	Leiden	Zuid-Holland
Netherlands	Radboud Universitair Medisch Centrum	Nijmegen	Gelderland
Netherlands	Erasmus Medisch Centrum	Rotterdam	Zuid-Holland
Netherlands	St. Franciscus Ziekenhuis	Rotterdam	Zuid-Holland
Poland	University hospital Krakow, J.P. II	Krakow
Poland	Sokolowski Pulmonary Hospital	Zakopane
United Kingdom	Chelsea and Westminster hospital	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Countries where clinical trial is conducted

Belgium,  Denmark,  Germany,  Netherlands,  Poland,  United Kingdom, 

References & Publications (6)

Annema JT, Veseliç M, Rabe KF. Endoscopic ultrasound-guided fine-needle aspiration for the diagnosis of sarcoidosis. Eur Respir J. 2005 Mar;25(3):405-9. — View Citation

Costabel U, Hunninghake GW. ATS/ERS/WASOG statement on sarcoidosis. Sarcoidosis Statement Committee. American Thoracic Society. European Respiratory Society. World Association for Sarcoidosis and Other Granulomatous Disorders. Eur Respir J. 1999 Oct;14(4):735-7. Review. — View Citation

Garwood S, Judson MA, Silvestri G, Hoda R, Fraig M, Doelken P. Endobronchial ultrasound for the diagnosis of pulmonary sarcoidosis. Chest. 2007 Oct;132(4):1298-304. Epub 2007 Sep 21. — View Citation

Iannuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med. 2007 Nov 22;357(21):2153-65. Review. — View Citation

Kantrow SP, Meyer KC, Kidd P, Raghu G. The CD4/CD8 ratio in BAL fluid is highly variable in sarcoidosis. Eur Respir J. 1997 Dec;10(12):2716-21. — View Citation

Winterbauer RH, Lammert J, Selland M, Wu R, Corley D, Springmeyer SC. Bronchoalveolar lavage cell populations in the diagnosis of sarcoidosis. Chest. 1993 Aug;104(2):352-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB)		within a week	No
Secondary	Assessment of complications of both the endosonography and conventional bronchoscopic workup		within 30 days	Yes
Secondary	The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis		2 weeks	No
Secondary	Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up.		within a week	No