In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients (MiPECSE)
Primary Purpose
Pulmonary Disease, Pulmonary Emphysema
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bronchoscopy with in vivo confocal endomicroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Disease
Eligibility 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
Sites / Locations
- Rouen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patients with a suspicion of emphysema
patients with a suspicion of scleroderma
Arm Description
A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema
A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia
Outcomes
Primary Outcome Measures
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
Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
Intercapillary distance is assessed using in vivo confocal endomicroscopy
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
Secondary Outcome Measures
Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma
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
Axial thickness of elastic fibers is assessed using in vivo confocal endomicroscopy
Full Information
NCT ID
NCT02556697
First Posted
September 17, 2015
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02556697
Brief Title
In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
Acronym
MiPECSE
Official Title
In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Pulmonary Emphysema
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with a suspicion of emphysema
Arm Type
Experimental
Arm Description
A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema
Arm Title
patients with a suspicion of scleroderma
Arm Type
Experimental
Arm Description
A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia
Intervention Type
Device
Intervention Name(s)
Bronchoscopy with in vivo confocal endomicroscopy
Intervention Description
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 Measure Information:
Title
Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
Description
Extra-alveolar diameter of capillaries is assessed using in vivo confocal endomicroscopy
Time Frame
Day 1
Title
Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
Description
Intercapillary distance is assessed using in vivo confocal endomicroscopy
Time Frame
Day 1
Title
Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma
Description
Length of the capillary is assessed using in vivo confocal endomicroscopy
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma
Description
Alveolar diameter entries is assessed using in vivo confocal endomicroscopy
Time Frame
Day 1
Title
Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma
Description
Axial thickness of elastic fibers is assessed using in vivo confocal endomicroscopy
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu SALAUN, MD
Email
mathieu.salaun@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu SALAUN, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc THIBERVILLE, Pr
12. IPD Sharing Statement
Learn more about this trial
In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
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