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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Endobronchial Mass
• Intervention / Treatment: Procedure: Endobronchial ultrasound transbronchial cryobiopsy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence LECERF; Phone Number: +33140942517; Email: f.lecerf@ghpsj.fr
• Study Contact Backup: Name: Amir HANNA; Phone Number: +33140942456; Email: a.hanna@ghpsj.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with mediastinal lymphadenopathy; 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.

Procedure: Endobronchial ultrasound transbronchial cryobiopsy; Endobronchial Ultrasound (EBUS) : EBUS is usually performed under general anesthesia using a laryngeal masque. It has a linear ultrasonography with a 7.5 MHz frequency. The distal part of the endoscope contains a water filled balloon used as a liquid interface, camera, light source and a working channel. The needle is protected by a sheath to prevent working channel damage. The endoscope is connected to a processor that reflects both endobronchial and ultrasound images on a screen. EBUS - TBNA : EBUS - Transbronchial needle aspiration EBUS - TBCB: EBUS - Transbronchial Cryo Biopsy; Other Names: Endobronchial ultrasound transbronchial cryobiopsy (EBUS-TBCB 1.1 mm probe) among patients with mediastinal lymphadenopathies.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Publications and helpful links

General Publications

• Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e211S-e250S. doi: 10.1378/chest.12-2355.
• Ernst A, Anantham D, Eberhardt R, Krasnik M, Herth FJ. Diagnosis of mediastinal adenopathy-real-time endobronchial ultrasound guided needle aspiration versus mediastinoscopy. J Thorac Oncol. 2008 Jun;3(6):577-82. doi: 10.1097/JTO.0b013e3181753b5e.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Patients with mediastinal lymphadenopathies.
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: 2023-A00969-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No