Recruiting

Observational Study

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT03573362

Conditions

Sarcoidosis

Lymphoma

Adenopathy Hilar

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ViziShot FLEX 19G needle

Vizishot 22G needle (standard)

Study Details

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

Study ID

NCT03573362

Start date

Jan 1, 2019

Status verified date

Feb, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Vizishot Flexneedle 19G

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

active comparator: Vizishot 22G

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

Interventions

ViziShot FLEX 19G needle

EBUS-TBNA using the ViziShot FLEX 19G needle

Vizishot 22G needle (standard)

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

Primary outcome measure

  • Diagnostic yield of EBUS-TBNA [ Time Frame: 12 months after enrollment of the last patient. ]

Central Contacts and Locations

Central contacts

Thomas Vandemoortele, MD, MSc

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

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Thomas Vandemoortele, MD, MSc

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

Principal Investigator:

Thomas Vandemoortele, MD, MSc

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 17, 2023

Last verified

Feb, 2023

Keywords

  • sarcoidosis
  • ebus
  • endobronchial ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2023-02-17.