Bronchoscopic Sampling Techniques in Sarcoidosis

Medical University of Warsaw

Status: Unknown

Conditions: Sarcoidosis; Lymphomas; Mediastinal Lymph Node Enlargement; Tuberculosis

Treatments: Procedure: Endobronchial forceps biopsy; Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA); Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB); Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodes; Procedure: Bronchoalveolar lavage (BAL)

Study type: Interventional

Funder types: Other

Identifiers

NCT01836822

IPU-DIMPA-WUM13(1)

Details and patient eligibility

About

The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. The aim of the study is to compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to obtain histological samples from MLN in patients with clinical and radiological features of sarcoidosis.

Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis.

Diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. Diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• provided informed consent
• mediastinal lymph node enlargement that requires bronchoscopy and transbronchial sampling
• clinical presentation that might be consistent with sarcoidosis

Exclusion criteria

• age below 18 years
• known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
• lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node involvement

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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90 participants in 1 patient group

Bronchoscopic lymph node sampling

Experimental group

Description:

Several different sampling techniques will be used in each patient. They include: EBUS guided transbronchial needle aspiration (EBUS-TBNA), EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histologic needle biopsy of the mediastinal lymph nodes, forceps biopsy of bronchial mucosa in central and peripheral bronchi

Treatment:

Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA)

Procedure: Endobronchial forceps biopsy

Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB)

Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodes

Procedure: Bronchoalveolar lavage (BAL)