Endobronchial Diagnosis of Lymphoma

NCT05075655 | Unknown

• 1 other identifier: 20-028
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• every adverse effect related to the procedure

  up to 3 years

Study Arms (1)

EBUS-MFB and EBUS-TBNA

EXPERIMENTAL

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

Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration

Interventions

Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration 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.

EBUS-MFB and EBUS-TBNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CaenUH

Caen, Normandy, 14000, France

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Romain M Magnier, MD

CONTACT

0291069029; magnier-r@chu-caen.fr

Pierre M Cuchet, MD

CONTACT

0231063029; cuchet-p@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: pathologist do not know the technique of sampling used when analysing slides.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 13, 2021
• Study Start: April 20, 2021
• Primary Completion: April 20, 2023
• Study Completion: September 1, 2023
• Last Updated: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)