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Bronchoscopic Sampling Techniques in Sarcoidosis

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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
Sponsor:
Information provided by (Responsible Party):
Rafał Krenke, Medical University of Warsaw

Tracking Information
First Submitted Date  ICMJE April 17, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date February 12, 2014
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
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 and large bore TBNA in terms of making the diagnosis of sarcoidosis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
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. 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)
Current Other Pre-specified Outcome Measures
 (submitted: April 19, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bronchoscopic Sampling Techniques in Sarcoidosis
Official Title  ICMJE Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Mediastinal Lymph Node Enlargement
  • Sarcoidosis
  • Tuberculosis
  • Lymphomas
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01836822
Other Study ID Numbers  ICMJE IPU-DIMPA-WUM13(1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rafał Krenke, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Warsaw
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP