Clinical trial NCT02556697: In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
Official title: In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease
Pulmonary Emphysema
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
timeFrame: Day 1
measure: Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
timeFrame: Day 1
measure: Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma
timeFrame: Day 1
Secondary outcomes:
measure: Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma
timeFrame: Day 1
measure: Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma
timeFrame: Day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Mathieu SALAUN, MD
role: PRINCIPAL_INVESTIGATOR
References: