Mediastinum Clinical Trial
Official title:
Value of Rapid on Site Evaluation During Endobronchial Ultrasound Guided Trans-bronchial Needle Aspiration (EBUS-TBNA) in the Diagnosis of Mediastinal Lesions
Verified date | April 2018 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective study will include 30 patients with hilar/mediastinal lymph nodes detected
by thoracic CT either there was a known lung malignancy (for staging purpose) or not (for
diagnosing purpose).
All patients will undergo to ROSE during EBUS-guided TBNA. Mediastinoscopy or other invasive
procedures will be performed if EBUS-guided TBNA doesn't provide representative material.
Status | Completed |
Enrollment | 67 |
Est. completion date | September 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Hilar/mediastinal lymph nodes with a short axis more than 1 cm on thoracic CT scan and/or PET-CT suspicious for malignancy with or without known lung malignancy. - Hilar and/or mediastinal lymph nodes positive on PET/CT scan without regarding the diameter suspicious for malignancy. - Recurrence or restaging of NSCLC after chemotherapy or radiation. - Diagnosis of lung cancer when there is no endobronchial lesion. - Diagnosis of both benign (especially tuberculosis and sarcoidosis) and malignant mediastinal lesions (eg. thymoma). Exclusion Criteria: - Cardiovascular instability. - Lack of patient cooperation, e.g. intractable cough, inability to remain motionless or altered consciousness. - Bleeding diathesis (activated partial thromboplastin time (APTT) ratio or international normalized ratio (INR) <1.3 or platelet count of <50000 per mm3). - Respiratory failure and patient on mechanical ventilation. - Severe chronic obstructive pulmonary disease (COPD) (FEV1<1 liter or <35% predicted). |
Country | Name | City | State |
---|---|---|---|
Egypt | Chest Department, Faculty of Medicine, Tanta University | Tanta | Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Cardoso AV, Neves I, Magalhães A, Sucena M, Barroca H, Fernandes G. The value of rapid on-site evaluation during EBUS-TBNA. Rev Port Pneumol (2006). 2015 Sep-Oct;21(5):253-8. doi: 10.1016/j.rppnen.2015.02.003. Epub 2015 Apr 1. — View Citation
Geake J, Hammerschlag G, Nguyen P, Wallbridge P, Jenkin GA, Korman TM, Jennings B, Johnson DF, Irving LB, Farmer M, Steinfort DP. Utility of EBUS-TBNA for diagnosis of mediastinal tuberculous lymphadenitis: a multicentre Australian experience. J Thorac Di — View Citation
Herth FJ, Krasnik M, Kahn N, Eberhardt R, Ernst A. Combined endoscopic-endobronchial ultrasound-guided fine-needle aspiration of mediastinal lymph nodes through a single bronchoscope in 150 patients with suspected lung cancer. Chest. 2010 Oct;138(4):790-4 — View Citation
Herth FJ, Rabe KF, Gasparini S, Annema JT. Transbronchial and transoesophageal (ultrasound-guided) needle aspirations for the analysis of mediastinal lesions. Eur Respir J. 2006 Dec;28(6):1264-75. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with accurate diagnosis of mediastinal lesions in relation to the total number studied. | 4-6 months |
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