Trial for the Diagnosis of Sarcoidosis

NCT00872612 | Completed Phase 3 DMC

• 1 other identifier: LUMC-GRANULOMA
• Study Type: interventional
• Target: 304
• Locations: 6 countries
• Sites: 15

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.

Conditions

Sarcoidosis

Keywords

Sarcoidosis; Diagnosis; Non-caseating granulomas; BAL; EUS-FNA; EBUS-TBNA; TBLB

Outcome Measures

Primary Outcomes (1)

• The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB)

  within a week

Secondary Outcomes (3)

• Assessment of complications of both the endosonography and conventional bronchoscopic workup

  within 30 days

• The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis

  2 weeks

• Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up.

  within a week

Study Arms (2)

A

EXPERIMENTAL

Endosonography arm

Procedure: EUS-FNA/EBUS-TBNA + BAL

B

ACTIVE COMPARATOR

Conventional bronchoscopy arm

Procedure: EBB + TBLB + BAL

Interventions

EUS-FNA/EBUS-TBNA + BAL PROCEDURE

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

A

EBB + TBLB + BAL PROCEDURE

EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (15)

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Gentofte Hospital Copenhagen

Hellerup, Copenhagen, 2900, Denmark

Location

Thoraxklinik Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Hospital Grosshansdorf

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

Rijnstaete Ziekenhuis

Arnhem, Gelderland, Netherlands

Location

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands

Location

St. Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Location

Pulmonary Department, Leiden University Medical Center

Leiden, South Holland, 2300 RC, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, South Holland, 3015 CE, Netherlands

Location

St. Franciscus Ziekenhuis

Rotterdam, South Holland, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, South Holland, Netherlands

Location

University hospital Krakow, J.P. II

Krakow, Poland

Location

Sokołowski Pulmonary Hospital

Zakopane, Poland

Location

Royal Brompton Hospital

London, London, United Kingdom

Location

Chelsea and Westminster hospital

London, SW10 9NH, United Kingdom

Location

Related Publications (7)

• 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. doi: 10.1034/j.1399-3003.1999.14d02.x. No abstract available.

  PMID: 10573213 BACKGROUND

• Iannuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med. 2007 Nov 22;357(21):2153-65. doi: 10.1056/NEJMra071714. No abstract available.

  PMID: 18032765 BACKGROUND

• 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. doi: 10.1378/chest.104.2.352.

  PMID: 8339618 BACKGROUND

• 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. doi: 10.1183/09031936.97.10122716.

  PMID: 9493649 BACKGROUND

• Annema JT, Veselic M, Rabe KF. Endoscopic ultrasound-guided fine-needle aspiration for the diagnosis of sarcoidosis. Eur Respir J. 2005 Mar;25(3):405-9. doi: 10.1183/09031936.05.00098404.

  PMID: 15738281 BACKGROUND

• 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. doi: 10.1378/chest.07-0998. Epub 2007 Sep 21.

  PMID: 17890467 BACKGROUND

• von Bartheld MB, Dekkers OM, Szlubowski A, Eberhardt R, Herth FJ, in 't Veen JC, de Jong YP, van der Heijden EH, Tournoy KG, Claussen M, van den Blink B, Shah PL, Zoumot Z, Clementsen P, Porsbjerg C, Mauad T, Bernardi FD, van Zwet EW, Rabe KF, Annema JT. Endosonography vs conventional bronchoscopy for the diagnosis of sarcoidosis: the GRANULOMA randomized clinical trial. JAMA. 2013 Jun 19;309(23):2457-64. doi: 10.1001/jama.2013.5823.

  PMID: 23780458 DERIVED

MeSH Terms

Conditions

Sarcoidosis; Disease

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• M B von Bartheld, MSc

  Pulmonary Department, Leiden University Medical Center

  STUDY DIRECTOR

• J T Annema, MD PhD

  Pulmonary Department, Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• K F Rabe, MD PhD

  Pulmonary Department, Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MB von Bartheld, MSc. PhD Student

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

DE (2); PL (2); NL (7); DK (1); GB (2); BE (1)