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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: patients with a suspicion of emphysema
    • A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema
  • Experimental: patients with a suspicion of scleroderma
    • A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma
    • Time Frame: 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
    • Time Frame: Day 1
    • Axial thickness of elastic fibers is assessed using in vivo confocal endomicroscopy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Rouen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mathieu SALAUN, MD, Principal Investigator, Rouen University Hospital
  • Overall Contact(s)
    • Mathieu SALAUN, MD, mathieu.salaun@chu-rouen.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.