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

NCT ID: NCT02556697

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-24
• Study Completion Date: 2018-05-07

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.

Conditions

Pulmonary Disease; Pulmonary Emphysema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients with a suspicion of emphysema

A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema

Group Type: EXPERIMENTAL

Bronchoscopy with in vivo confocal endomicroscopy

Intervention Type: DEVICE

A bronchoscopy with in vivo confocal endomicroscopy is done for patients with a suspicion of emphysema or for patients with a suspicion of scleroderma

patients with a suspicion of scleroderma

A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia

Group Type: EXPERIMENTAL

Bronchoscopy with in vivo confocal endomicroscopy

Intervention Type: DEVICE

A bronchoscopy with in vivo confocal endomicroscopy is done for patients with a suspicion of emphysema or for patients with a suspicion of scleroderma

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathieu SALAUN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2013/093/HP

Identifier Type: -

Identifier Source: org_study_id