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Trial for the Diagnosis of Sarcoidosis (GRANULOMA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Leiden University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
M.B. von Bartheld, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00872612
First received: March 30, 2009
Last updated: January 3, 2012
Last verified: January 2012

March 30, 2009
January 3, 2012
March 2009
November 2011   (final data collection date for primary outcome measure)
The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB) [ Time Frame: within a week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00872612 on ClinicalTrials.gov Archive Site
  • Assessment of complications of both the endosonography and conventional bronchoscopic workup [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  • The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up. [ Time Frame: within a week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial for the Diagnosis of Sarcoidosis
Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Sarcoidosis
  • 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

  • Procedure: EBB + TBLB + BAL
    EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage
  • Experimental: A
    Endosonography arm
    Intervention: Procedure: EUS-FNA/EBUS-TBNA + BAL
  • Active Comparator: B
    Conventional bronchoscopy arm
    Intervention: Procedure: EBB + TBLB + BAL

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
304
May 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   Germany,   Netherlands,   Poland,   United Kingdom
 
NCT00872612
LUMC-GRANULOMA
Yes
M.B. von Bartheld, Leiden University Medical Center
Leiden University Medical Center
Not Provided
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
Leiden University Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP