In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
研究概览
简要总结
Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. The alterations in lung microvessels are found in pulmonary involvement of scleroderma, which are the most serious complications of the disease.
In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are involved in the onset and development of the disease.
The confocal endomicroscopy is an endoscopic technique which can be performed during a bronchoscopy. This technique makes it possible to observe in real time the most distal pulmonary elements at the microscopic scale. After injection of fluorescein, then the technique of observing the pulmonary microvasculature, in vivo and in situ.
The characterization of microvascular lesions in these two pathologies could improve understanding of their mechanisms and ultimately improve the early management of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 scleroderma with diffuse interstitial pneumonia, indicating a bronchoscopy.
- •Patients with pulmonary emphysema indication for bronchoscopy.
- •Age greater than 18 years.
- •Having an affiliation to social security.
- •Signed informed consent.
排除标准
- •Severe chronic respiratory insufficiency against-indicating the completion of a bronchoscopy
- •Hypercapnia defined by a PaCO2 ≥ 6 kPa
- •Disorders of hemostasis against-indicating performing a bronchoscopy
- •Anticoagulant therapy can not be interrupted time of completion of the examination
- •A history of pneumonectomy or contralateral exploration in a nonfunctional lung
- •Contraindication to the injection of fluorescein (including treatment with beta-blocker eye drops or po) or one of its excipients
- •History of an injection poorly tolerated fluorescein
- •A history of food allergy or drug known
- •Myocardial infarction <1 month
- •Unstable angina
- •Pregnant or lactating woman, premenopausal women without adequate contraception
- •Person under guardianship
- •Patient participating in another trial / participating in another trial within 4 weeks
研究组 & 干预措施
patients with a suspicion of emphysema
A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema
干预措施: Bronchoscopy with in vivo confocal endomicroscopy (Device)
patients with a suspicion of scleroderma
A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia
干预措施: Bronchoscopy with in vivo confocal endomicroscopy (Device)
结局指标
主要结局
Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
时间窗: Day 1
Extra-alveolar diameter of capillaries is assessed using in vivo confocal endomicroscopy
Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
时间窗: Day 1
Intercapillary distance is assessed using in vivo confocal endomicroscopy
Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma
时间窗: Day 1
Length of the capillary is assessed using in vivo confocal endomicroscopy
次要结局
- Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma(Day 1)
- Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma(Day 1)