Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 15
- 主要终点
- The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB)
研究概览
简要总结
This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II.
The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).
Also the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.
Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.
详细描述
Sarcoidosis is the most prevalent interstitial lung disease in Western-Europe and the US. The disease is most prevalent in young adults. To set the final diagnosis of sarcoidosis, the following parameters need to be present:
- A clinical and radiological suspicion of sarcoidosis stage I/II.
- A tissue diagnosis of disease-specific non-caseating granulomas.
- Exclusion of possible alternative diagnoses as lung cancer or tuberculosis.
Nowadays, a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis. However, these biopsies are only diagnostic in 70% of the procedures and they are associated with a 3% risk of coughing up blood and a 4% risk of a lung collapse.
Since recently, a new diagnostic procedure has come available. This procedure, endo-sonography, makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85%. The associated risk of complications appears to be small (<1%)
We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography. We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of 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
- •Patients with suspected pulmonary sarcoidosis stage I/ II
- •Age > 18 years
- •Both males and females
- •Written informed consent is obtained.
排除标准
- •Patients with obvious other organ involvement of sarcoidosis where a simple diagnostic biopsy to assess granulomas can be performed.
- •Löfgren's syndrome
- •Inability to undergo fiberbronchoscopy, EBUS or EUS (e.g. respiratory insufficiency, esophageal stenosis
- •Contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia)
- •Pregnancy
- •Inability to obtain informed consent
研究组 & 干预措施
A
Endosonography arm
干预措施: EUS-FNA/EBUS-TBNA + BAL (Procedure)
B
Conventional bronchoscopy arm
干预措施: EBB + TBLB + BAL (Procedure)
结局指标
主要结局
The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB)
时间窗: within a week
次要结局
- The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis(2 weeks)
- Assessment of complications of both the endosonography and conventional bronchoscopic workup(within 30 days)
- Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up.(within a week)
研究者
M.B. von Bartheld
MB von Bartheld, MSc. PhD Student
Leiden University Medical Center