Have you or your loved ones been diagnosed with pulmonary disease?

You may be eligible to participate in a pulmonary disease clinical trial.

Have you or your loved ones been diagnosed with pulmonary disease? You may be eligible to participate in a pulmonary disease clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Pulmonary Disease Clinical Trial in Rouen

NCT02556697 | Interventional

Have you or your loved ones been diagnosed with pulmonary disease?

You may be eligible to participate in a pulmonary disease clinical trial.

Have you or your loved ones been diagnosed with pulmonary disease? You may be eligible to participate in a pulmonary disease clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 60 Participants

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.

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Details for the study

Brief Title

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

Official Title

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

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.

Treatments and/or Procedures

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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 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

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

Study 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