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

Pulmonary Disease Clinical Trial

— MiPECSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02556697
• Other study ID #: 2013/093/HP
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: Mathieu SALAUN, MD
• Email: mathieu.salaun[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Lung Diseases
• Pulmonary Disease
• Pulmonary Emphysema
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Device:
• Bronchoscopy with in vivo confocal endomicroscopy
A bronchoscopy with in vivo confocal endomicroscopy is done for patients with a suspicion of emphysema or for patients with a suspicion of scleroderma

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma	Extra-alveolar diameter of capillaries is assessed using in vivo confocal endomicroscopy	Day 1
Primary	Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma	Intercapillary distance is assessed using in vivo confocal endomicroscopy	Day 1
Primary	Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma	Length of the capillary is assessed using in vivo confocal endomicroscopy	Day 1
Secondary	Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma	Alveolar diameter entries is assessed using in vivo confocal endomicroscopy	Day 1
Secondary	Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma	Axial thickness of elastic fibers is assessed using in vivo confocal endomicroscopy	Day 1