In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients (MiPECSE)

University Hospital, Rouen

Status: Completed

Conditions: Pulmonary Emphysema; Pulmonary Disease

Treatments: Device: Bronchoscopy with in vivo confocal endomicroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02556697

2013/093/HP

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

patients with a suspicion of emphysema

Experimental group

Description:

A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema

Treatment:

Device: Bronchoscopy with in vivo confocal endomicroscopy

patients with a suspicion of scleroderma

Experimental group

Description:

A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia

Treatment:

Device: Bronchoscopy with in vivo confocal endomicroscopy