Endobronchial vs. Esophageal Ultrasound for Diagnosing Sarcoidosis: A Randomized Clinical Trial; - A Standard vs. - ProCore Needle Comparison -
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.
研究概览
简要总结
Rationale:
Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion.
Secondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates.
Hypotheses:
- Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal sampling in patients with suspected sarcoidosis stage I/II.
- 25G ProCore needles provide superior sample quality compared to conventional 22G needles in patients with suspected sarcoidosis stage I/II.
Study design:
Investigator initiated, randomized clinical trial. Setting: International, multicenter (university and general hospitals)
Study population:
Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II and an indication for tissue verification of non-caseating granulomas are eligible for inclusion.
Intervention:
EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.
Main study endpoints:
- The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.
- Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities)
- •Indication for tissue verification of noncaseating granuloma's
- •Provision of a written informed consent
排除标准
- •Life expectancy of less than 6 months
- •Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node)
- •Positive acid-fast bacilli sputum test
- •Contra-indication for endosonography
- •Pregnancy
结局指标
主要结局
Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.
时间窗: 9 months after inclusion of last patient.
The sample quality will be assessed by two independent reference pathologists. The performance of each needle (25 ProCore / standard 22 G) will be scored on five items (the modified Mair score).
The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.
时间窗: 2 weeks after the endosonography procedure.
次要结局
未报告次要终点
研究者
L.M.M. Crombag
MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)