Endobronchial Diagnosis of Lymphoma

Lymphoma Clinical Trial

— EnDol  

Official title:

Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05075655
• Other study ID #: 20-028
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: September 2023

Study information

• Verified date: September 2021
• Source: University Hospital, Caen
• Contact: Romain M Magnier, MD
• Phone: 0291069029
• Email: magnier-r[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: September 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Device:
• Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration
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.

Locations

Country	Name	City	State
France	CaenUH	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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