Endobronchial Diagnosis of Lymphoma

Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05075655

Acronym

EnDol

Enrollment

Registered

2021-10-13

Start date

2021-04-20

Completion date

2023-09-30

Last updated

2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

ebus, endobronchial ultrasound-guided, EBUS-MFB, intra-nodal miniforceps biopsy, EBUS-transbronchial forceps biopsy

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

Interventions

DEVICEEndobronchial 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.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

pathologist do not know the technique of sampling used when analysing slides.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactRomain M Magnier, MD

magnier-r@chu-caen.fr0291069029

Backup ContactPierre M Cuchet, MD

cuchet-p@chu-caen.fr0231063029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026