Recruiting

Menghini-type & Franseen-type

Sponsor:

University Health Network, Toronto

Code:

NCT06220526

Conditions

Suspected Sarcoidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Suspected Sarcoidosis

Study ID

NCT06220526

Start date

Aug 18, 2023

Status verified date

Apr, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • -Any adult patient aged 18 years or older with enlarged mediastinal and/or hilar lymph nodes
  • (≥10 mm short-axis diameter on a CT scan), suspected as having sarcoidosis based on clinical
  • history, physical exam, and other investigations, and booked for EBUS-TBNA.

Exclusion Criteria:

  • -Patients that are unable to provide informed consent

\- Patients with lymphadenopathy strongly suspected to be secondary to other diseases based on
  • clinical history, physical exam, and/or other investigations (e.g., lung cancer, lymphoma,
  • infection).

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Menghini-type needle

the standard needle type

active comparator: Franseen-type needles

the active comparator arm

Interventions

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

Transbronchial biopsy with Menghini-type or Franseen type Needle

Primary outcome measure

  • Rate of adequate tissue sampling from lymph nodes (as determined by pathologists) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Judy McConnell

416-581-7849judy.mcconnell@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1L7

Contacts

Judy McConnell, BSc.Hon, CCRP

416-581-7486judy.mcconnell@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.