Mediastinum Clinical Trial
Official title:
The Role of Endobronchial Ultrasound Elastography 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 |
The 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 EBUS-guided TBNA. Elastography will be performed on all lymph
nodes that will be candidates for EBUS TBNA. Mediastinoscopy or other invasive procedures
will be performed if EBUS-guided TBNA doesn't provide representative material.
Status | Completed |
Enrollment | 56 |
Est. completion date | June 2016 |
Est. primary completion date | April 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 both benign and malignant mediastinal lesions. 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). - Border line 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,
Jiang JH, Turner JF Jr, Huang JA. Endobronchial ultrasound elastography: a new method in endobronchial ultrasound-guided transbronchial needle aspiration. J Thorac Dis. 2015 Dec;7(Suppl 4):S272-8. doi: 10.3978/j.issn.2072-1439.2015.12.53. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with correct diagnosis of mediastinal lesions (benign or malignant) using elastography | 6 months. |
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