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

Endobronchial Mass Clinical Trial

— EBUS-CRYO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250387
• Other study ID #: 2023-A00969-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Fondation Hôpital Saint-Joseph
• Contact: Amir HANNA
• Phone: +33140942456
• Email: a.hanna[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endobronchial Mass
• Lymphadenopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

References & 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. — View Citation

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. — View Citation

Outcome

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