Endobronchial Diagnosis of Lymphoma

NCT ID: NCT05075655

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2023-09-30

Brief Summary

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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

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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

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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EBUS-MFB and EBUS-TBNA

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

Group Type EXPERIMENTAL

Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CaenUH

Caen, Normandy, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Romain M Magnier, MD

Role: CONTACT

0291069029 ext. +33

Pierre M Cuchet, MD

Role: CONTACT

0231063029 ext. +33

Facility Contacts

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Dutheil M Jean-Jacques

Role: primary

0231065351 ext. +33

Other Identifiers

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20-028

Identifier Type: -

Identifier Source: org_study_id