EnDol: Endobronchial Diagnosis of Lymphoma

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05075655
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 28.4
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Device: Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Masking Description: pathologist do not know the technique of sampling used when analysing slides.
• Primary Purpose: Diagnostic
• Official Title: Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.
• Actual Study Start Date: Apr 20, 2021
• Anticipated Primary Completion Date: Apr 20, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CaenUH	Caen	Normandy	France	14000

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT05075655
• Other Study ID Numbers: 20-028
• First Posted: Oct 13, 2021
• Last Update Posted: Oct 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Caen: ebus; endobronchial ultrasound-guided; EBUS-MFB; intra-nodal miniforceps biopsy; EBUS-transbronchial forceps biopsy
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Oct 13, 2021