Trial for the Diagnosis of Sarcoidosis (GRANULOMA)

Leiden University Medical Center (LUMC)

Status and phase: Completed; Phase 3

Conditions: Sarcoidosis

Treatments: Procedure: EBB + TBLB + BAL; Procedure: EUS-FNA/EBUS-TBNA + BAL

Study type: Interventional

Funder types: Other

Identifiers

NCT00872612

LUMC-GRANULOMA

Details and patient eligibility

About

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.

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We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography.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

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups

A

Experimental group

Description:

Endosonography arm

Treatment:

Procedure: EUS-FNA/EBUS-TBNA + BAL

B

Active Comparator group

Description:

Conventional bronchoscopy arm

Treatment:

Procedure: EBB + TBLB + BAL