Endobronchial Diagnosis of Lymphoma (EnDol)

September 29, 2021 updated by: University Hospital, Caen

Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, 14000
        • Recruiting
        • CaenUH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBUS-MFB and EBUS-TBNA
patient will have both TBNA and MFB in the same operating time
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positivity of the procedure in Diagnosis and Subtyping of lymphoma
Time Frame: up to 3 years
a sample wil be considered positive if it allows the clinical management of the patient, without additional sampling required.
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
every adverse effect related to the procedure
Time Frame: up to 3 years
infectious process related to the procedure, hemoptysis over 50cc, worsening of respiratory status requiring hospitalization
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Anticipated)

April 20, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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