Overview

This trial is active, not recruiting.

Condition sarcoidosis
Treatments eus-fna/ebus-tbna + bal, ebb + tblb + bal
Phase phase 3
Sponsor Leiden University Medical Center
Start date March 2009
End date November 2011
Trial size 304 participants
Trial identifier NCT00872612, LUMC-GRANULOMA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Endosonography arm
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)
Conventional bronchoscopy arm
ebb + tblb + bal
EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage

Primary Outcomes

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

Secondary Outcomes

Measure
Assessment of complications of both the endosonography and conventional bronchoscopic workup
time frame: within 30 days
The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis
time frame: 2 weeks
Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up.
time frame: within a week

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial
Principal investigator J T Annema, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Leiden University Medical Center.