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Bronchoscopic Sampling Techniques in Sarcoidosis

Primary Purpose

Mediastinal Lymph Node Enlargement, Sarcoidosis, Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
EBUS guided transbronchial forceps biopsy (EBUS-TBFB)
EBUS guided transbronchial needle aspiration (EBUS-TBNA)
large bore (19G) histologic needle biopsy of the mediastinal lymph nodes
Bronchoalveolar lavage (BAL)
Endobronchial forceps biopsy
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mediastinal Lymph Node Enlargement focused on measuring 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)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine, Pneumonology and Allergology, Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bronchoscopic lymph node sampling

Arm Description

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

Outcomes

Primary Outcome Measures

Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
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.
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)

Full Information

First Posted
April 17, 2013
Last Updated
February 11, 2014
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01836822
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchoscopic lymph node sampling
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
EBUS guided transbronchial forceps biopsy (EBUS-TBFB)
Other Intervention Name(s)
EBUS guided miniforceps biopsy
Intervention Type
Procedure
Intervention Name(s)
EBUS guided transbronchial needle aspiration (EBUS-TBNA)
Intervention Type
Procedure
Intervention Name(s)
large bore (19G) histologic needle biopsy of the mediastinal lymph nodes
Intervention Type
Procedure
Intervention Name(s)
Bronchoalveolar lavage (BAL)
Intervention Type
Procedure
Intervention Name(s)
Endobronchial forceps biopsy
Primary Outcome Measure Information:
Title
Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
Description
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.
Time Frame
Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available
Secondary Outcome Measure Information:
Title
Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.
Description
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)
Time Frame
up to 9 months
Other Pre-specified Outcome Measures:
Title
Local complications of mediastinal lymph node sampling
Description
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
Time Frame
During and 24 hrs after bronchoscopic procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafal Krenke, MD, PhD
Email
rafalkrenke@interia.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Korczynski, MD, PhD
Email
drkorczynski@gmail.com
Facility Information:
Facility Name
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Krenke, MD, PhD
Phone
+48225992562
Email
rafalkrenke@interia.pl
First Name & Middle Initial & Last Name & Degree
Piotr Korczynski, MD, PhD
Phone
+48225992562
Email
drkorczynski@gmail.com
First Name & Middle Initial & Last Name & Degree
Rafal Krenke, MD, PhD
First Name & Middle Initial & Last Name & Degree
Piotr Korczynski, MD, PhD

12. IPD Sharing Statement

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Bronchoscopic Sampling Techniques in Sarcoidosis

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