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

University Health Network, Toronto

Status: Enrolling

Conditions: Suspected Sarcoidosis

Treatments: Device: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06220526

23-5265

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Menghini-type needle

Other group

Description:

the standard needle type

Treatment:

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

Franseen-type needles

Active Comparator group

Description:

the active comparator arm

Treatment:

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