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NCT Number: NCT00872612

Trial for the Diagnosis of Sarcoidosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitair Ziekenhuis Gent, Ghent, Belgium

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About this study

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:

  • A clinical and radiological suspicion of sarcoidosis stage I/II.
  • A tissue diagnosis of disease-specific non-caseating granulomas.
  • 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We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

EBB + TBLB + BAL

Procedure

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

Primary outcomes

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

    Time frame: within a week

Secondary outcomes

  1. Assessment of complications of both the endosonography and conventional bronchoscopic workup

    Time frame: within 30 days

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

    Time frame: 2 weeks

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

    Time frame: within a week

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: GRANULOMA

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Mar 31, 2009
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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