Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases (Microsemio-PI)

Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases : A Multicentric Prospective Study

Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of DPLD is often challenging, because of the large number of pathological entities involved, which share close clinical and radiological presentations. High resolution Chest CT, a key diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations, so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling. This invasive procedure is not devoid of morbidity and may be impossible to perform in fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a multi-disciplinary expert consensus, based on careful medical history, chest CT and bronchoalveolar lavage examinations.

Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric clinical trial at the Rouen University Hospital in more than 200 patients and healthy volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and confirmed the safety of the technique.

Study Overview

• Status: Unknown
• Conditions: Diffuse Parenchymal Lung Diseases
• Intervention / Treatment: Procedure: Bronchoscopy; Procedure: Confocal microendoscopy; Procedure: Biopsy sampling

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luc THIBERVILLE, Pr; Email: luc.thiverville@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • ROUEN university hospital
    • Contact: Luc THIBERVILLE, Pr; Email: luc.thiberville@chu-rouen.fr
    • Principal Investigator: Luc THIBERVILLE, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age ≥ 18
• signed written informed consent
• indication for a flexible bronchoscopy
• DPLD characterized by clinical and radiological data compatible with : idiopathic pulmonary fibrosis (IPF), acute or chronic hypersensitivity pneumonitis (HPS), sarcoidosis, or asbestosis.
• Initial histological confirmation of the disease is not required for the inclusion of the patient and the realisation of the alveolar bronchoscopy.
• non-smoking or smoking cessation >6 month
• Patient affiliated with, or beneficiary of a social security category

Exclusion Criteria:

• respiratory failure and contraindication for a flexible bronchoscopy (this item will stay at the appreciation of the physician, arterial blood gaz sampling being not required)
• bleeding disorder which would be not compatible with the realization of a flexible bronchoscopy
• history of pneumonectomy or non functional lung controlateral to the pCLE procedure
• patients for which a per-endoscopic distal lung cryobiopsy is forecasted during the first diagnostic bronchoscopy,
• patients for which the bronchoscopy needs a general anesthesia and mechanical ventilation during the procedure
• anticoagulant or platelet aggregation inhibitors that cannot be interrupted for the flexible bronchoscopy
• patients for which a follow up or an adequate work-up to achieve the final diagnosis will not be possible.
• patients for which a cryobiopsy is forecasted during the bronchoscopy
• pregnant and breast feeding women, or women of childbearing potential not taking adequate contraception
• Patients unable to understand informed consent
• Patient on major legal measure of protection
• Patients participating in an other interventional clinical trial at the inclusion date

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient who need to undergo bronchoscopy; Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done

Procedure: Bronchoscopy; Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done; Procedure: Confocal microendoscopy; Confocal microendoscopy will be performed during this initial bronchoscopy; Procedure: Biopsy sampling; Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule	Confocal imaging will be considered as "positive" when both; a solid pattern is displayed; a diagnostic biopsy is obtained at the site of confocal imaging	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Luc THIBERVILLE, Pr, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 2014/208/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No