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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
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 17, 2015
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
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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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