EBUS-TBNA Versus EBUS-TBNB

Study Overview
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Brief Summary
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A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB). The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.

Official Title
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Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial

Conditions
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Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Carcinoma, Lymphoma, Sarcoidosis, Mycobacterial Disease

Intervention / Treatment
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* Device: Endobronchial ultrasound guided lymph node sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for EBUS-TBNA as part of clinical care Lymph nodes larger than 10mm in diameter Age > 18 years Able to provide written informed consent Exclusion Criteria: Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) Inability to obtain informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EBUS-TBNA<br>Sampling using endobronchial ultrasound guided transbronchial needle aspiration | Device: Endobronchial ultrasound guided lymph node sampling<br>* Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.<br>* Other names: Olympus EBUS-TBNB biopsy forceps;|
| Experimental: EBUS-TBNB<br>Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle. | Device: Endobronchial ultrasound guided lymph node sampling<br>* Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.<br>* Other names: Olympus EBUS-TBNB biopsy forceps;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms. | The definition of a definitive diagnosis is dependant on the diagnosis and is clarified below: Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour. Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas. Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the complication rate between the two study arms |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial ultrasound, Transbronchial needle aspiration, Transbronchial biopsy forceps, Mediastinal lymphadenopathy, Hilar lymphadenopathy