Endobronchial Diagnosis of Lymphoma

Study Overview
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Brief Summary
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The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of de novo mediastinal lymphoma.

Detailed Description
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Every patients will be sampled using both EBUS-MFB and the standard of care EBUS-TBNA (transbronchial needle aspiration). It is a monocentric investigation. Pathologist will not know the way of sampling while analysing the samples

Official Title
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Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.

Conditions
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Lymphoma

Intervention / Treatment
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* Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological mediastinal nodes within reach of EBUS sampling on CT-scan. Lymphoma suspicion by a senior clinical hematologist Affiliated to the french public health care insurance Exclusion Criteria: Peripherical pathological lymph nodes reachable without general anesthesia Antithrombotic medication that cannot be stopped le time of the procedure. Unstable respiratory status History of lymphoma Latex or xylocaine allergia

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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS-MFB and EBUS-TBNA<br>patient will have both TBNA and MFB in the same operating time | Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration<br>* Mediastinal node is sampled using three path of classic ultrasound guided transbronchial needle aspiration (EBUS-TBNA). A reduce size forceps is then inserted inside the mediastinal node via the duc EBUS-TBNA made and biopsies (EBUS-MFB) are made using real time ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positivity of the procedure in Diagnosis and Subtyping of lymphoma | a sample wil be considered positive if it allows the clinical management of the patient, without additional sampling required. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| every adverse effect related to the procedure | infectious process related to the procedure, hemoptysis over 50cc, worsening of respiratory status requiring hospitalization | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ebus, endobronchial ultrasound-guided, EBUS-MFB, intra-nodal miniforceps biopsy, EBUS-transbronchial forceps biopsy