Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Sarcoidosis

Treatments: Procedure: Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00888212

2008/069

Details and patient eligibility

About

The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 y
• Suspicion of thoracic sarcoidosis and need for tissue confirmation
• Recent (<6 weeks) RX and CT-thorax (HRCT not compulsory)
• Fit for bronchoscopy (with or without EBB, TBB, TBNA), esophagoscopy and surgery
• Written informed consent

Exclusion criteria

• Patients with obvious other organ involvement allowing "simple and safe" biopsy
• Lofgren syndrome
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Bronchoscopy

Experimental group

Description:

Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy

Treatment:

Procedure: Bronchoscopy