Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma
Primary Purpose
Sarcoidosis, Lymphoma, Adenopathy Hilar
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ViziShot FLEX 19G needle
Vizishot 22G needle (standard)
Sponsored by
About this trial
This is an interventional diagnostic trial for Sarcoidosis focused on measuring sarcoidosis, ebus, endobronchial ultrasound
Eligibility Criteria
Inclusion criteria
- Patient t referred for specimens by EBUS -TBNA with clinical and radiological suspicion of sarcoidosis or lymphoma , with pathological lymph node on imaging (small diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal stations, sub-carinal and / or hilar (stations 2, 4, 7, 10, 11 and 12), right and / or left.
- Lymph nodes with a small diameter of at least 0.5 cm in CT-scan or PET / CT scan performed in the previous 4-6 weeks.
- Patient investigated in the setting of either an initial diagnosis or a suspicion of lymphoma recurrence (post-treatment).
- Patient able to consent to the procedure and to authorize us by written proxy, included in the consent form for the study, to obtain a copy of the subsequent results or radiological (PET, CT-scan, chest X-ray) or histopathological (linked with age sampled of intrathoracic lymph nodes).
- Patient deemed fit to tolerate the procedure.
Exclusion criteria
- Patient unable to give consent.
- Female patient during pregnancy
- Patient aged under 18.
- Patient with significant coagulopathy ( INR > 1.5 ; platelet count<50 000 / mm 3 ).
- Patient anticoagulated (oral or parenteral) and whose anticoagulation can not be suspended for the procedure.
- Obvious involvement of organ (s) with the possibility of confirming granulomas or suspicious cells of lymphoma by means of a procedure considered less invasive (.. e g, lymph node biopsy of cervical, supraclavicular or inguinal nodes; skin biopsy).
Sites / Locations
- Centre hospitalier de l'Université de Montréal (CHUM)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vizishot Flexneedle 19G
Vizishot 22G
Arm Description
Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle
Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle
Outcomes
Primary Outcome Measures
Diagnostic yield of EBUS-TBNA
The diagnostic yield of EBUS TBNA with 19G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two, using McNemar test on paired proportions.
Secondary Outcome Measures
Ease of use.
Evaluate the ease of use of both types of needles. Using a visual analog scale (from 0 most difficult to 10 very easy to use), ease of use of each needle will be assessed and compared for each lymph node.
Specimen quality
Samples will be considered adequate if the cytologic assessment shows lymphocytes and or definite if the specimen shows epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body). The samples will be classified as: diagnostic, adequate but non-diagnostic, non-diagnostic and not adequate, no specimen
Complications
Complications encountered with both needle sizes will be compared if there is any difference in the rate of complications, specifically pneumothorax, endobronchial bleeding, post-bronchoscopy bleeding, pneumonia, respiratory infection, hospitalization required because of the procedure, respiratory failure, death.
Full Information
NCT ID
NCT03573362
First Posted
May 15, 2018
Last Updated
February 15, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT03573362
Brief Title
Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma
Official Title
Prospective Trial Comparing the Diagnostic Yield of Two Different Needle Sizes Used in EBUS-TBNA for Sarcoidosis and Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . There is also a role in cases of isolated hilar and mediastinal lymph nodes in which the differential diagnosis includes mostly sarcoidosis, lymphoma and tuberculosis. 3
Various studies have evaluated more recently the diagnostic yield of EBUS-TBNA specifically for sarcoidosis 4 and thoracic lymphoma 5-6. Although there is emerging data supporting the usefulness of EBUS-TBNA in the investigation of these two pathologies, the efficacy results vary according to the target populations and certain parameters. Moreover, although a large randomized study demonstrated e superiority of EBUS-TBNA over conventional bronchoscopic sampling methods [ bronchoalveolar lavage (BAL) and trans-bronchial biopsies (TBB ] for the diagnosis of sarcoidosis , 7 the results suggest that there is still room for optimizing the performance of EBUS-TBNA [b] . In the field of lymphoma, obtaining large enough specimens for adequate subtyping also remains a concern. 8
In order to improve the performance of EBUS -TBNA , new needles have been developed with the aim to provide biopsies for histological evaluation rather than purely cytological. The ViziShot FLEX © (Olympus) 19 gauge needle (19 gauge or 19G) is a large needle, which can provide both tissue and needle aspiration , and has the advantage of being more flexible.
For this study, the investigators want to compare the diagnostic yield of EBUS-TBNA using needle ViziShot FLEX 19G (1.11 mm) with that of the standard 22G needle ( NA-201SX; Olympus) , in the investigation of hilar or mediastinal lymphadenopathy suspected to be sarcoidosis or lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Lymphoma, Adenopathy Hilar
Keywords
sarcoidosis, ebus, endobronchial ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vizishot Flexneedle 19G
Arm Type
Experimental
Arm Description
Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle
Arm Title
Vizishot 22G
Arm Type
Active Comparator
Arm Description
Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle
Intervention Type
Device
Intervention Name(s)
ViziShot FLEX 19G needle
Intervention Description
EBUS-TBNA using the ViziShot FLEX 19G needle
Intervention Type
Device
Intervention Name(s)
Vizishot 22G needle (standard)
Intervention Description
EBUS-TBNA using the Vizishot 22G needle (standard)
Primary Outcome Measure Information:
Title
Diagnostic yield of EBUS-TBNA
Description
The diagnostic yield of EBUS TBNA with 19G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two, using McNemar test on paired proportions.
Time Frame
12 months after enrollment of the last patient.
Secondary Outcome Measure Information:
Title
Ease of use.
Description
Evaluate the ease of use of both types of needles. Using a visual analog scale (from 0 most difficult to 10 very easy to use), ease of use of each needle will be assessed and compared for each lymph node.
Time Frame
1 week after enrollment of last patient.
Title
Specimen quality
Description
Samples will be considered adequate if the cytologic assessment shows lymphocytes and or definite if the specimen shows epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body). The samples will be classified as: diagnostic, adequate but non-diagnostic, non-diagnostic and not adequate, no specimen
Time Frame
1 week after enrollment of last patient
Title
Complications
Description
Complications encountered with both needle sizes will be compared if there is any difference in the rate of complications, specifically pneumothorax, endobronchial bleeding, post-bronchoscopy bleeding, pneumonia, respiratory infection, hospitalization required because of the procedure, respiratory failure, death.
Time Frame
1 month after enrollment of last patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Patient t referred for specimens by EBUS -TBNA with clinical and radiological suspicion of sarcoidosis or lymphoma , with pathological lymph node on imaging (small diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal stations, sub-carinal and / or hilar (stations 2, 4, 7, 10, 11 and 12), right and / or left.
Lymph nodes with a small diameter of at least 0.5 cm in CT-scan or PET / CT scan performed in the previous 4-6 weeks.
Patient investigated in the setting of either an initial diagnosis or a suspicion of lymphoma recurrence (post-treatment).
Patient able to consent to the procedure and to authorize us by written proxy, included in the consent form for the study, to obtain a copy of the subsequent results or radiological (PET, CT-scan, chest X-ray) or histopathological (linked with age sampled of intrathoracic lymph nodes).
Patient deemed fit to tolerate the procedure.
Exclusion criteria
Patient unable to give consent.
Female patient during pregnancy
Patient aged under 18.
Patient with significant coagulopathy ( INR > 1.5 ; platelet count<50 000 / mm 3 ).
Patient anticoagulated (oral or parenteral) and whose anticoagulation can not be suspended for the procedure.
Obvious involvement of organ (s) with the possibility of confirming granulomas or suspicious cells of lymphoma by means of a procedure considered less invasive (.. e g, lymph node biopsy of cervical, supraclavicular or inguinal nodes; skin biopsy).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Vandemoortele, MD, MSc
Phone
514-890-8000
Ext
25151
Email
thomas.vandemoortele@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Vandemoortele, MD, MSc
Organizational Affiliation
CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Vandemoortele, MD, MSc
Phone
514-890-8000
Ext
25151
Email
thomas.vandemoortele@me.com
First Name & Middle Initial & Last Name & Degree
Thomas Vandemoortele, MD, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma
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