Comparing Menghini-type Needle and Franseen-type Needle in EBUS-TBNA for Sarcoidosis

Last updated: June 19, 2024
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoidosis

Treatment

endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)

Clinical Study ID

NCT06220526
23-5265
  • Ages > 18
  • All Genders

Study Summary

This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • -Any adult patient aged 18 years or older with enlarged mediastinal and/or hilarlymph nodes

  • (≥10 mm short-axis diameter on a CT scan), suspected as having sarcoidosis based onclinical

  • history, physical exam, and other investigations, and booked for EBUS-TBNA.

Exclusion

Exclusion Criteria:

  • -Patients that are unable to provide informed consent

  • Patients with lymphadenopathy strongly suspected to be secondary to otherdiseases based on

  • clinical history, physical exam, and/or other investigations (e.g., lung cancer,lymphoma,

  • infection).

Study Design

Total Participants: 128
Treatment Group(s): 1
Primary Treatment: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Phase:
Study Start date:
August 18, 2023
Estimated Completion Date:
February 28, 2026

Study Description

This study is a prospective randomized control trial. More than 370 lymph nodes from approximately 128 patients with enlarged mediastinal and/or hilar lymph nodes (≥10 mm short-axis diameter on CT scan) and suspected sarcoidosis will be enrolled in this study. This is a single-center study conducted at the Toronto General Hospital.

If consent is obtained, patients will be considered enrolled. The patients will then be assigned to either Menghini-type (the standard needle type in Toronto General Hospital) or Franseen-type needles in a 1:1 ratio with stratified randomization by the availability of rapid on-site cytology evaluation. An automated randomization program will be used to generate the randomization scheme for the study. Samples from mediastinal and hilar lymph nodes will be obtained by EBUS-guided Menghini-type or Franseen-type needle biopsy. Post-procedural assessment will take place in the endoscopy recovery room and will include, but not limited to, monitoring of vital signs, signs of bleeding, and pulmonary status. As EBUS-TBNA is an outpatient procedure, patients will be discharged home after the procedure.

Specimens (cell pellet and/or tissue fragment) will be assessed by pathologists as per their usual practice. The pathologists will remain blinded to the allocated needle. Specimens will be classified by their adequacy for histological assessment and diagnostic yield. In addition, total procedure time and mean number of needle passes to obtain tissue samples will be compared between the two study arms.

Connect with a study center

  • Toronto General Hospital

    Toronto, Ontario M5G 1L7
    Canada

    Active - Recruiting

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