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Trial record 2 of 101 for:    Emphysema | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

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

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ClinicalTrials.gov Identifier: NCT02556697
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease Pulmonary Emphysema Device: Bronchoscopy with in vivo confocal endomicroscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with a suspicion of emphysema
A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema
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

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556697


Contacts
Contact: Mathieu SALAUN, MD mathieu.salaun@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76031
Sub-Investigator: Luc THIBERVILLE, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Mathieu SALAUN, MD Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02556697     History of Changes
Other Study ID Numbers: 2013/093/HP
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Lung Diseases
Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Scleroderma, Systemic
Scleroderma, Diffuse
Respiratory Tract Diseases
Pathologic Processes
Connective Tissue Diseases
Skin Diseases