Bronchoscopic Sampling Techniques in Sarcoidosis

Not Applicable

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

• Registration Number: NCT01836822
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-22
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12
• Primary Completion: 2014-03
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.	Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available	Comparison of the diagnostic yield of the cytologic and histologic specimens collected by EBUS-TBNA, EBUS-TBFB, large bore TBNA, endobronchial forceps biopsy and BAL in terms of making the diagnosis of sarcoidosis.

Secondary Outcome Measures

Name	Time	Method
Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.	up to 9 months	Comparison of the number of patients in whom the specific sampling method has been undertaken (e.g. BAL, EBUS-TBNA, EBUS-TBFB and large bore TBNA) with the number of patients in whom the specific sampling method provided the adequate specimens, containing the elements of granulomas (also the relationship between the mediastinal lymph node dimension and the quality of the samples collected with different techniques)

Trial Locations

Locations (1)

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw; 🇵🇱 Warsaw, Poland