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

Not Applicable

Recruiting

• Conditions: Sarcoidosis; Lymphoma; Adenopathy Hilar
• Interventions: Device: ViziShot FLEX 19G needle; Device: Vizishot 22G needle (standard)

• Registration Number: NCT03573362
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Study Start: 2019-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17
• Primary Completion: 2025-01-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vizishot Flexneedle 19G	ViziShot FLEX 19G needle	Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle
Vizishot 22G	Vizishot 22G needle (standard)	Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of EBUS-TBNA	12 months after enrollment of the last patient.	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

Name	Time	Method
Ease of use.	1 week after enrollment of last patient.	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	1 week after enrollment of last patient	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	1 month after enrollment of last patient	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.

Trial Locations

Locations (1)

Centre hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada