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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir HANNA | Contact | +33140942456 | a.hanna@ghpsj.fr | |
| Florence LECERF | Contact | +33140942517 | f.lecerf@ghpsj.fr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18520794 | Background | 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. | |
| 23649440 | 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. |
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| 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 |