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

Not Applicable

• Conditions: Pulmonary Disease; Pulmonary Emphysema
• Interventions: Device: Bronchoscopy with in vivo confocal endomicroscopy

• Registration Number: NCT02556697
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-29
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with a suspicion of scleroderma	Bronchoscopy with in vivo confocal endomicroscopy	A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia
patients with a suspicion of emphysema	Bronchoscopy with in vivo confocal endomicroscopy	A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema

Primary Outcome Measures

Name	Time	Method
Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma	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	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	Day 1	Length of the capillary is assessed using in vivo confocal endomicroscopy

Secondary Outcome Measures

Name	Time	Method
Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma	Day 1	Alveolar diameter entries is assessed using in vivo confocal endomicroscopy
Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma	Day 1	Axial thickness of elastic fibers is assessed using in vivo confocal endomicroscopy

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France