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

NCT02556697 | Terminated

• 1 other identifier: 2013/093/HP
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma

  Day 1

• Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma

  Day 1

Study Arms (2)

patients with a suspicion of emphysema

EXPERIMENTAL

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

Device: Bronchoscopy with in vivo confocal endomicroscopy

patients with a suspicion of scleroderma

EXPERIMENTAL

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

Device: Bronchoscopy with in vivo confocal endomicroscopy

Interventions

Bronchoscopy with in vivo confocal endomicroscopy 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 emphysema; patients with a suspicion of scleroderma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Lung Diseases; Pulmonary Emphysema

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Mathieu SALAUN, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 22, 2015
• Study Start: November 24, 2014
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)