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

Not Applicable

Not yet recruiting

• Conditions: Endobronchial Mass
• Interventions: Procedure: Endobronchial ultrasound transbronchial cryobiopsy

• Registration Number: NCT06250387
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study Start: 2024-02
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-08
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with mediastinal lymphadenopathy	Endobronchial ultrasound transbronchial cryobiopsy	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.

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility of EBUS TBCB 1.1 mm probe.	6 Months	Number of successes of the procedure. A success is defined by the ability to perform a biopsy.

Secondary Outcome Measures

Name	Time	Method
To estimate the sensitivity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.	7 Months	anapathology analysis
To estimate the specificity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.	7 Months
To assess the post-procedure complications rate.	1 Month
To estimate the procedure time.	Day 0	The procedure time is defined by the time elapsed between introduction and removal of the EBUS probe