GRANULOMA: Trial for the Diagnosis of Sarcoidosis

• Sponsor: Leiden University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00872612
• Collaborator: (none)
• Enrollment: 304
• Locations: 15
• Arms: 2
• Duration (Months): 38
• Patients Per Site: 20.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis	Procedure: EUS-FNA/EBUS-TBNA + BAL; Procedure: EBB + TBLB + BAL	Phase 3

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We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography.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 Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Endosonography arm	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
Active Comparator: B Conventional bronchoscopy arm	Procedure: EBB + TBLB + BAL; EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage

Outcome Measures

Primary Outcome Measures

1. 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

1. Assessment of complications of both the endosonography and conventional bronchoscopic workup [within 30 days]

2. The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis [2 weeks]

3. Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up. [within a week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Gent	Gent		Belgium	9000
2	Gentofte Hospital Copenhagen	Hellerup	Copenhagen	Denmark	2900
3	Thoraxklinik Heidelberg	Heidelberg	Baden-Württemberg	Germany	69126
4	Hospital Grosshansdorf	Grosshansdorf	Schleswig-Holstein	Germany	22927
5	Rijnstaete Ziekenhuis	Arnhem	Gelderland	Netherlands
6	Radboud Universitair Medisch Centrum	Nijmegen	Gelderland	Netherlands
7	St. Catharina Ziekenhuis	Eindhoven	Noord-Brabant	Netherlands
8	Medisch Centrum Haaglanden	Den Haag	Zuid-Holland	Netherlands
9	Pulmonary Department, Leiden University Medical Center	Leiden	Zuid-Holland	Netherlands	2300 RC
10	Erasmus Medisch Centrum	Rotterdam	Zuid-Holland	Netherlands	3015 CE
11	St. Franciscus Ziekenhuis	Rotterdam	Zuid-Holland	Netherlands
12	University hospital Krakow, J.P. II	Krakow		Poland
13	Sokołowski Pulmonary Hospital	Zakopane		Poland
14	Chelsea and Westminster hospital	London		United Kingdom	SW10 9NH
15	Royal Brompton Hospital	London		United Kingdom

Sponsors and Collaborators

• Leiden University Medical Center

Investigators

• Study Director: M B von Bartheld, MSc, Pulmonary Department, Leiden University Medical Center
• Principal Investigator: J T Annema, MD PhD, Pulmonary Department, Leiden University Medical Center
• Principal Investigator: K F Rabe, MD PhD, Pulmonary Department, Leiden University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: M.B. von Bartheld, MB von Bartheld, MSc. PhD Student, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT00872612
• Other Study ID Numbers: LUMC-GRANULOMA
• First Posted: Mar 31, 2009
• Last Update Posted: Dec 7, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by M.B. von Bartheld, MB von Bartheld, MSc. PhD Student, Leiden University Medical Center: Sarcoidosis; Diagnosis; Non-caseating granulomas; BAL; EUS-FNA; EBUS-TBNA; TBLB
• Additional relevant MeSH terms: Sarcoidosis

Study Results

No Results Posted as of Dec 7, 2015