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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06250387

Acronym

EBUS-CRYO

Enrollment

Registered

2024-02-09

Start date

2024-02-29

Completion date

2024-09-30

Last updated

2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endobronchial Mass

Keywords

Patients with mediastinal lymphadenopathies.

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).

Interventions

PROCEDUREEndobronchial 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 estimate the procedure time.	Day 0	The procedure time is defined by the time elapsed between introduction and removal of the EBUS probe
To assess the post-procedure complications rate.	1 Month	—

Contacts

Primary ContactAmir HANNA

a.hanna@ghpsj.fr+33140942456

Backup ContactFlorence LECERF

f.lecerf@ghpsj.fr+33140942517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026