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Endobronchial Diagnosis of Lymphoma (EnDol)

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma focused on measuring ebus, endobronchial ultrasound-guided, EBUS-MFB, intra-nodal miniforceps biopsy, EBUS-transbronchial forceps biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CaenUHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EBUS-MFB and EBUS-TBNA

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

every adverse effect related to the procedure
infectious process related to the procedure, hemoptysis over 50cc, worsening of respiratory status requiring hospitalization

Full Information

First Posted
September 15, 2021
Last Updated
September 29, 2021
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05075655
Brief Title
Endobronchial Diagnosis of Lymphoma
Acronym
EnDol
Official Title
Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
ebus, endobronchial ultrasound-guided, EBUS-MFB, intra-nodal miniforceps biopsy, EBUS-transbronchial forceps biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Masking Description
pathologist do not know the technique of sampling used when analysing slides.
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EBUS-MFB and EBUS-TBNA
Arm Type
Experimental
Arm Description
patient will have both TBNA and MFB in the same operating time
Intervention Type
Device
Intervention Name(s)
Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration
Intervention Description
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.
Primary Outcome Measure Information:
Title
positivity of the procedure in Diagnosis and Subtyping of lymphoma
Description
a sample wil be considered positive if it allows the clinical management of the patient, without additional sampling required.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
every adverse effect related to the procedure
Description
infectious process related to the procedure, hemoptysis over 50cc, worsening of respiratory status requiring hospitalization
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romain M Magnier, MD
Phone
0291069029
Ext
+33
Email
magnier-r@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre M Cuchet, MD
Phone
0231063029
Ext
+33
Email
cuchet-p@chu-caen.fr
Facility Information:
Facility Name
CaenUH
City
Caen
State/Province
Normandy
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dutheil M Jean-Jacques
Phone
0231065351
Ext
+33
Email
dutheil-jj@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endobronchial Diagnosis of Lymphoma

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