Clinical trial NCT01836822: Bronchoscopic Sampling Techniques in Sarcoidosis
Official title: Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mediastinal Lymph Node Enlargement
Sarcoidosis
Tuberculosis
Lymphomas
Keywords: mediastinal lymph node enlargement
sarcoidosis
bronchoscopy
EBUS guided transbronchial needle aspiration (EBUS-TBNA)
transbronchial needle aspiration (EBUS-TBNA)
EBUS guided transbronchial forceps biopsy EBUS-TBFB)
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
timeFrame: Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available
Secondary outcomes:
measure: Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.
timeFrame: up to 9 months
Other outcomes:
measure: Local complications of mediastinal lymph node sampling
timeFrame: During and 24 hrs after bronchoscopic procedure
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Study officials:
References: