NCT06220526

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

A Prospective Randomized Clinical Trial Comparing Menghini-type Needle and Franseen-type Needle for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Pathological Diagnosis of Sarcoidosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Suspected Sarcoidosis

Interventions

Type	Name	Description
DEVICE	endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)	Transbronchial biopsy with Menghini-type or Franseen type Needle

Timeline

• Start date: 2023-08-18
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-01-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: Canada