Prospective Feasibility Study of Endobronchial Ultrasound Transbronchial Cryobiopsy (EBUS-TBCB 1.1 mm Probe) Among Patients With Mediastinal Lymphadenopathies (EBUS-CRYO)

Fondation Hôpital Saint-Joseph

Status: Not yet enrolling

Conditions: Endobronchial Mass

Treatments: Procedure: Endobronchial ultrasound transbronchial cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06250387

2023-A00969-36

Details and patient eligibility

About

Mediastinal lymph nodes enlargement with short axis diameter >15 mm is conventionally defined as a mediastinal lymphadenopathy. The causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥ 18 years of age
• Mediastinal and/or hilar lymphadenopathies > 20 mm on an injected chest CT scan
• Suspicion of lymphoproliferative disease, sarcoidosis or tuberculosis
• Hypermetabolism of mediastinal and/or hilar lymphadenopathies on PET scan (SUV max > 3)
• No contraindication for general anesthesia
• French-speaking Patient
• -Signed informed consent

Exclusion criteria

• Patient not covered by the French social security system
• Patient with legal protection
• Pregnant or breastfeeding patient (if applicable)
• Patient under guardianship or curatorship
• Patient deprived of liberty

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients with mediastinal lymphadenopathy

Experimental group

Description:

Patients with suspicion of lymphoma, sarcoidosis and tuberculosis, presenting with mediastinal lymphadenopathy confirmed by a CT scan and/ or PET scan and patients with previous negative EBUS-TBNA.

Treatment:

Procedure: Endobronchial ultrasound transbronchial cryobiopsy