Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma

NCT03573362 | Unknown FDA Device

• 1 other identifier: 2017-6844
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis; Lymphoma; Adenopathy Hilar

Keywords

sarcoidosis; ebus; endobronchial ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after enrollment of the last patient.

Secondary Outcomes (3)

• Ease of use.

  1 week after enrollment of last patient.

• Specimen quality

  1 week after enrollment of last patient

• Complications

  1 month after enrollment of last patient

Study Arms (2)

Vizishot Flexneedle 19G

EXPERIMENTAL

Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle

Device: ViziShot FLEX 19G needle

Vizishot 22G

ACTIVE COMPARATOR

Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle

Device: Vizishot 22G needle (standard)

Interventions

ViziShot FLEX 19G needle DEVICE

EBUS-TBNA using the ViziShot FLEX 19G needle

Vizishot Flexneedle 19G

Vizishot 22G needle (standard) DEVICE

EBUS-TBNA using the Vizishot 22G needle (standard)

Vizishot 22G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Sarcoidosis; Lymphoma

Interventions

Needles

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Thomas Vandemoortele, MD, MSc

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Vandemoortele, MD, MSc

CONTACT

514-890-8000; thomas.vandemoortele@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 29, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

CA (1)