Diagnostic Value of EBUS-Guided Transbronchial Mediastinal Cryobiopsy Versus Conventional Bronchoscopic Approaches for Stage I/II Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 469
- 试验地点
- 1
- 主要终点
- The granuloma detection rate
研究概览
简要总结
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. This randomized controlled trial aims to compare directly the diagnostic yield between EBUS-TBMC and EBUS-TBNA+EBB+TBLB in sarcoidosis.
详细描述
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. Two questions remain need to be answered: (1) Does EBUS-TBMC have the same or better diagnostic sensitivity for sarcoidosis than EBUS-TBNA combined with standard bronchoscopic modalities (EBB or/and TBLB)? (2) Can combining EBUS-TBMC with standard bronchoscopic modalities further increase the diagnostic sensitivity for sarcoidosis? This study is designed as a randomised controlled trial to compare the diagnostic yield between EBUS-TBMC and conventional bronchoscopic approaches for diagnosing stage I/II sarcoidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 ≥18years;
- •Patients with clinical and radiological suspicion of stage I or stage II sarcoidosis;
- •Fully informed of the purpose and method of the study
排除标准
- •Pathologically confirmed sarcoidosis, obvious organ involvement with the possibility of confirming granulomas using a minimally invasive diagnostic procedure;
- •Patients with medical contraindications to bronchoscopy procedures.
研究组 & 干预措施
EBUS-TBNA
Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA
干预措施: EBUS-TBNA-based sampling methods (Procedure)
EBUS-TBMC
Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC
干预措施: EBUS-TBMC based sampling method (Procedure)
结局指标
主要结局
The granuloma detection rate
时间窗: 7 days after sampling
The number of patients with granulomas detected relative to the total number of patients tested.
次要结局
- Negative predictive value(6 months after sampling)
- Diagnostic yield(6 Month after sampling)
- Incidence of complications(4 weeks after sampling)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital