Safety and Efficacy of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy in the diagnosis of Mediastinal lesions :A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Safety and efficacy of Endobronchial Ultrasound-Guided Cryobiopsy in the Mediastinal lesions.Safety is determined by complications and efficacy is determined by positive biopsy results
研究概览
简要总结
After CTRI Approval our study will enroll patients presenting to Pulmonary Medicine Department with undiagnosed mediastinal lymphadenopathy who requires definite diagnosis with pathological examination based on inclusion and exclusion criteria
Aim
To determine the safety and efficacy of the Endobronchial ultrasound-Guided Mediastinal cryobiopsy (EBUS-MCB) in mediastinal lesions (>1cm)
Primary Objective
1. To determine procedural safety of EBUS-MCB by rate of procedure-related complications like pneumothorax, bleeding, mediastinitis and pneumomediastinum
2. Efficacy will be determined by percentage of patients for whom mediastinal biopsy provides a definite diagnosis
Secondary Objective
To compare the diagnostic yield of EBUS-TBNA and EBUS-MCB in mediastinal lesions(>1cm)
Summary
.The procedure will be carried out under general Anaesthesia using the laryngeal mask airway/I gel/ET Tube .After this airways will be visualised and Endobronchial Ultrasound-guided Transbronchial Aspiration will be done. After this through the same track created, Cryobiopsy probe will be introduced and Endobronchial Ultrasound guided Mediastinal Cryobiopsy(EBUS-MCB) will be done .At least 3 cryobiopsy specimens will be obtained. Complications if any will be noted during the procedure .A post procedure chest radiograph will be obtained in all cases.All the samples collected will be sent for pathological examination. Patients will be followed up after 24 hrs and till 2 weeks(on call) to see if any delayed complications.Pathogical report will be collected and diagnosis will be done based on the report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age Greater than 18 years 2.Patients with undiagnosed mediastinal lesions greater than 1 cm requiring pathology examination for diagnosis.
排除标准
- •1.Age less than 18 years 2.Highly Vascular,necrotic lymph nodes and unhealthy mucosa at the site of biopsy 3.uncorrectable severe coagulation abnormalities 4.Refractory hypoxemia(sp02 less than 90% with fio2 more than 60) 5.Unstable cardiac arrhythmias,Severe Pulmonary Hypertension(RVSP greater than 50mmHg) 6.Recent MI (less than 4 weeks) or ongoing unstable angina 7.Benign/malignant stenosis of upper airway.
结局指标
主要结局
Safety and efficacy of Endobronchial Ultrasound-Guided Cryobiopsy in the Mediastinal lesions.Safety is determined by complications and efficacy is determined by positive biopsy results
时间窗: Safety at time of study(baseline) and till 2 weeks | Efficacy at the time of study (baseline)
次要结局
- Yield of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy vs Endobronchial Ultrasound-guided Fine needle Aspiration
研究者
Dr Kuruva Sai Anudeep
Aiims Jodhpur