Bronchoscopic Sampling Techniques in Sarcoidosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01836822|
Recruitment Status : Unknown
Verified February 2014 by Rafał Krenke, Medical University of Warsaw.
Recruitment status was: Recruiting
First Posted : April 22, 2013
Last Update Posted : February 12, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Mediastinal Lymph Node Enlargement Sarcoidosis Tuberculosis Lymphomas||Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB) Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA) Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodes Procedure: Bronchoalveolar lavage (BAL) Procedure: Endobronchial forceps biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||May 2014|
Experimental: Bronchoscopic lymph node sampling
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
Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB)
Other Name: EBUS guided miniforceps biopsy
Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA)
Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodes
Procedure: Bronchoalveolar lavage (BAL)
Procedure: Endobronchial forceps biopsy
- Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis. [ Time Frame: 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.
- Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease. [ Time Frame: 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)
- Local complications of mediastinal lymph node sampling [ Time Frame: During and 24 hrs after bronchoscopic procedure ]The number of patients in whom mediastinal vessels would be injured (resulting in endobronchial or extrabronchial bleeding). The number of patients with pneumothorax and/or pneumomediastinum complicating mediastinal sampling
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836822
|Contact: Rafal Krenke, MD, PhDemail@example.com|
|Contact: Piotr Korczynski, MD, PhDfirstname.lastname@example.org|
|Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw||Recruiting|
|Warsaw, Poland, 02-097|
|Contact: Rafal Krenke, MD, PhD +48225992562 email@example.com|
|Contact: Piotr Korczynski, MD, PhD +48225992562 firstname.lastname@example.org|
|Principal Investigator: Rafal Krenke, MD, PhD|
|Sub-Investigator: Piotr Korczynski, MD, PhD|