NCT00888212已完成不适用
Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
研究概览
简要总结
The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.
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
- •Age ≥ 18 y
- •Suspicion of thoracic sarcoidosis and need for tissue confirmation
- •Recent (<6 weeks) RX and CT-thorax (HRCT not compulsory)
- •Fit for bronchoscopy (with or without EBB, TBB, TBNA), esophagoscopy and surgery
- •Written informed consent
排除标准
- •Patients with obvious other organ involvement allowing "simple and safe" biopsy
- •Lofgren syndrome
- •Pregnancy
结局指标
主要结局
The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
时间窗: At the end of study
The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy
时间窗: At the end of study
次要结局
- Prevalence of sarcoidosis and alternate diagnosis(At the end of study)
- Stage distribution(At the end of study)
- Complication rate of each type of procedure(At the end of study)
- Cost to obtain a qualifying diagnosis with this strategy in this population(At the end of study)
研究者
研究点 (16)
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