Endobronchial Diagnosis of Lymphoma

Not Applicable

• Conditions: Lymphoma

• 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

Study Timeline

• Study Start: 2021-04-20
• Status Verified: 2021-09
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13
• Primary Completion: 2023-04-20
• Study Completion: 2023-09

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

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