Endobronchial Diagnosis of Lymphoma (EnDol)

Caen University Hospital

Status: Unknown

Conditions: Lymphoma

Treatments: Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT05075655

20-028

Details and patient eligibility

About

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.

Full 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

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 1 patient group

EBUS-MFB and EBUS-TBNA

Experimental group

Description:

patient will have both TBNA and MFB in the same operating time

Treatment:

Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration