Trial record 9 of 38 for:    Open Studies | "Sarcoidosis"

Bronchoscopic Sampling Techniques in Sarcoidosis

This study is currently recruiting participants.
Verified February 2014 by Medical University of Warsaw
Sponsor:
Information provided by (Responsible Party):
Rafał Krenke, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01836822
First received: April 17, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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)


Other Outcome Measures:
  • Local complications of mediastinal lymph node sampling [ Time Frame: During and 24 hrs after bronchoscopic procedure ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01836822

Contacts
Contact: Rafal Krenke, MD, PhD rafalkrenke@interia.pl
Contact: Piotr Korczynski, MD, PhD drkorczynski@gmail.com

Locations
Poland
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw Recruiting
Warsaw, Poland, 02-097
Contact: Rafal Krenke, MD, PhD    +48225992562    rafalkrenke@interia.pl   
Contact: Piotr Korczynski, MD, PhD    +48225992562    drkorczynski@gmail.com   
Principal Investigator: Rafal Krenke, MD, PhD         
Sub-Investigator: Piotr Korczynski, MD, PhD         
Sponsors and Collaborators
Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Rafał Krenke, MD, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01836822     History of Changes
Other Study ID Numbers: IPU-DIMPA-WUM13(1)
Study First Received: April 17, 2013
Last Updated: February 11, 2014
Health Authority: Poland: Bioethics Appeals Commission

Keywords provided by Medical University of Warsaw:
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)

Additional relevant MeSH terms:
Sarcoidosis
Hypertrophy
Lymphoma
Tuberculosis
Lymphatic Diseases
Pathological Conditions, Anatomical
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014