Comparing Menghini-type Needle and Franseen-type Needle in EBUS-TBNA for Sarcoidosis
NCT ID: NCT06220526
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2023-08-18
2026-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Menghini-type needle
the standard needle type
endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Transbronchial biopsy with Menghini-type or Franseen type Needle
Franseen-type needles
the active comparator arm
endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Transbronchial biopsy with Menghini-type or Franseen type Needle
Interventions
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endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Transbronchial biopsy with Menghini-type or Franseen type Needle
Eligibility Criteria
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Inclusion Criteria
* (≥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 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).
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Kazuhiro Yasufuku
Department Head. Division of Thoracic Surgery
Principal Investigators
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Kazuhiro Yasufuku
Role: PRINCIPAL_INVESTIGATOR
UHN
Locations
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Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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a
Role: backup
Other Identifiers
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23-5265
Identifier Type: -
Identifier Source: org_study_id
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