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

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 Overview

• Status: Terminated
• Conditions: Pulmonary Emphysema; Pulmonary Disease
• Intervention / Treatment: Device: Bronchoscopy with in vivo confocal endomicroscopy

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma	Intercapillary distance is assessed using in vivo confocal endomicroscopy	Day 1
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Mathieu SALAUN, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2014
• Primary Completion (Actual): May 7, 2018
• Study Completion (Actual): May 7, 2018

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimated): September 22, 2015

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pathological Conditions, Signs and Symptoms; Lung Diseases; Pulmonary Emphysema; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Diagnostic Techniques, Respiratory System; Thoracic Surgical Procedures; Pulmonary Surgical Procedures; Bronchoscopy
• Other Study ID Numbers: 2013/093/HP