Comparing Menghini-type Needle and Franseen-type Needle in EBUS-TBNA for Sarcoidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).
- Who it may be relevant to
- Registry conditions: Suspected Sarcoidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Transbronchial biopsy with Menghini-type or Franseen type Needle
Primary outcome measures
- Rate of adequate tissue sampling from lymph nodes (as determined by pathologists) [Time frame: 3 years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Toronto General Hospital — Toronto
Identifiers
NCT: NCT06220526 · 23-5265