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

NCT06250387 | Unknown

• 1 other identifier: 2023-A00969-36
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Endobronchial Mass

Keywords

Patients with mediastinal lymphadenopathies.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To estimate the sensitivity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.

  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.

  Day 0

• To assess the post-procedure complications rate.

  1 Month

Study Arms (1)

Patients with mediastinal lymphadenopathy

EXPERIMENTAL

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

Interventions

Endobronchial ultrasound transbronchial cryobiopsy PROCEDURE

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

Also known as: Endobronchial ultrasound transbronchial cryobiopsy (EBUS-TBCB 1.1 mm probe) among patients with mediastinal lymphadenopathies.

Patients with mediastinal lymphadenopathy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Related Publications (2)

• 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.

  PMID: 18520794 BACKGROUND

• 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.

  PMID: 23649440 BACKGROUND

Central Study Contacts

Amir HANNA

CONTACT

+33140942456; a.hanna@ghpsj.fr

Florence LECERF

CONTACT

+33140942517; f.lecerf@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 9, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-01