Value of Rapid on Site Evaluation During Endobronchial Ultrasound Guided Trans-bronchial Needle Aspiration (EBUS-TBNA) in the Diagnosis of Mediastinal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Number of participants with accurate diagnosis of mediastinal lesions in relation to the total number studied.
研究概览
简要总结
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.
详细描述
All patients will be subjected to the following parameters:
- Thorough history taking and full clinical examination.
- Chest X-ray (postro-anterior and lateral views) before and after the procedure.
- Recent Computed Tomography (CT chest) with contrast.
- Laboratory studies:
- Complete liver functions.
- Blood urea and serum creatinine.
- Complete blood picture (including platelet count).
- Erythrocyte sedimentation rate (ESR).
- Fasting and postprandial blood sugar.
- Preoperative evaluation: Pulmonary function tests (PFT), Electrocardiogram (ECG), arterial blood gases (ABG) and coagulation profile (including bleeding & clotting times, prothrombin time& activity and activated partial thromboplastin time (APTT)) and oral anticoagulants should be stopped before the procedure for at least 48 hours.
- Color doppler ultrasound in suspected vascular lesions.
- Clinical and radiological follow up of patients over 1 week after the procedure to detect the occurrence of any complications.
- The biopsy samples will be examined histopathologically. EBUS-TBNA will be done within 10 days of CT examination under local anesthesia and conscious sedation.
Convex Probe EBUS- Guided TBNA EBUS-guided TBNA examinations will be performed at both Tanta University Educational Hospital and Kobry Elkoba Military Hospital using Pantex EBUS probe and Hitachi ultrasound in the supine position under local anesthesia with lidocaine and conscious sedation.
Lymph nodes will be identified according to the Mountain's regional lymph node classification system (17). The lymph node stations of 2, 4, 7, 10 and 11 were evaluated systematically. During the process for every detected lymph node; short and long axis diameters, station of the lymph node, number of passes per patient and per lymph node were recorded for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Patients with mediastinal lesions
EBUS TBNA of mediastinal lesions or lymph nodes
干预措施: EBUS TBNA of mediastinal lesions or lymph nodes (Procedure)
结局指标
主要结局
Number of participants with accurate diagnosis of mediastinal lesions in relation to the total number studied.
时间窗: 4-6 months
次要结局
未报告次要终点
研究者
Adel Salah Bediwy
Professor
Tanta University