Endobronchial Diagnosis of Lymphoma
Not Applicable
- Conditions
- Lymphoma
- Interventions
- Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration
- Registration Number
- NCT05075655
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description EBUS-MFB and EBUS-TBNA Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration patient will have both TBNA and MFB in the same operating time
- Primary Outcome Measures
Name Time Method positivity of the procedure in Diagnosis and Subtyping of lymphoma up to 3 years a sample wil be considered positive if it allows the clinical management of the patient, without additional sampling required.
- Secondary Outcome Measures
Name Time Method every adverse effect related to the procedure up to 3 years infectious process related to the procedure, hemoptysis over 50cc, worsening of respiratory status requiring hospitalization
Trial Locations
- Locations (1)
CaenUH
🇫🇷Caen, Normandy, France