Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

Mini Invasive Probe Based Confocal Laser Endomicroscopy of the Pleura for Malignancies Diagnosis

Recently, probe based confocal laser endomicroscopy showed to be able to distinguish malignant from benign pleura during medical thoracoscopy. However The clinical usefulness of this new tool remains to be determined.

The investigators believe that pCLE could be part of mini invasive pleural disease management and could be used during thoracentesis in order to increase the diagnostic yield of this procedure. The investigators are starting a prospective trial to recruit patients referred for medical thoracoscopy to the endoscopy unit.

First, the pCLE probe will be introduced through the Boutin's needle or the thoracentesis catheter, just before the thoracoscopy, in order to investigate the pleural pCLE features and to identify or exclude malignant infiltration. Second those features will be compared to the pCLE acquisition obtained during the medical thoracoscopy (the probe is introduced through the working chanel of the thoracoscope), under visual control. In order to compare the invasive and mini invasive acquisition, 10 criteria will be prospectively assessed.Third, These features will be compared to the histological samples performed during thoracoscopy. Finally, the interpretation of different investigators will be compared.

The 10 criteria are presented below:

1. Abnormal tissular architecture

   No: Correct identification of the previously described normal pleura characteristics Yes: identification of cellular/tissular structures which are not known to correspond to normal pleura (cellular clusters or dark clumps, glands, cells cordons, dysmorphic cells, papillar distribution….)

2. Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator

   yes no

3. Mean cellular size:

   Small: < 10µm Moderate: 10 - 20µm Large: > 20µm

4. Cellular density (with reference to the Chia seed sign)

   Low (lower than the Chia seed sign) Moderate High

5. Dysplastic vessels:

   Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia

6. Vascular density (on a full optical area)

   Low: 0 -2 vessels Moderate: 3 - 4 vessels High: > 4 vessels

7. Organized or anarchic connective fibers

   Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture.

8. Chia seed sign on a full optical areal

yes No

Study Overview

• Status: Completed
• Conditions: Pleural Diseases; Pleural Neoplasms
• Intervention / Treatment: Device: Probe based confocal laser endomicroscopy of the pleura

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

• Study Contact: Name: Bonhomme Olivier, M.D; Phone Number: 0032 043667881; Email: obonhomme@chuliege.be
• Study Contact Backup: Name: Duysinx Bernard, PhD; Phone Number: 0032 043667881; Email: Bduysinx@chuliege.be

Study Locations

• Belgium
  • Liege, Belgium, 4020
    • Olivier Bonhomme

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Every patient referred to the endoscopy unit for medical thoracoscopy

Description

Inclusion Criteria:

• Every patient referred to the endoscopy unit for medical thoracoscopy

Exclusion Criteria:

• Pregnancy
• Known allergy to the fluorescein

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, specificity, positive predictive value and negative predictive value of mini invasive pleural pCLE assessment to identify malignant pleural infiltration.	Before medical thoracoscopy, the pCLE probe will be introduced through the Boutin's needle or the thoracentesis catheter. The pleural pCLE acquisition will be assessed by two experienced and unblinded clinicians (aware of the medical history of the patient) during the procedure. A second acquisition and assessment of the criteria is performed thereafter during the medical thoracoscopy. 10 preselected criteria are used to assess the pCLE acquisition. They are the same than previously published (Bonhomme et al respirology 2020). A third blinded (not aware of the medical history of the patient) investigator will revise the pCLE acquisition (not the same day) to perform the same assessment.	For the unblinded investigator: assessment of the videos is performed during the acquisition. For the blinded investigator, the assessment is performed within 30 days from the acquisition.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the pCLE acquisition and assessment of the 10 preselected criteria between the mini invasive acquisition (during thoracentesis) and the invasive acquisition (during thoracoscopy)	The pCLE features assessed during the mini invasive procedure will be compared to the assessment performed during the thoracoscopy. This assessment will be performed by the blinded investigator. The investigator will not know wether the pCLE acquisition is from mini invasive or invasive procedure for his assessment. The 10 criteria assessed during mini invasive or invasive pleural assessment will be compared to determine their reproducibility. The results will be presented for each criteria as the proportion of concordance between mini and invasive assessment.	Within 30 days from the acquisition of the pCLE videos.
inter-observator reproducibility of the pCLE interpretation and assessment of the 10 criteria.	The assessment of the 10 criteria will be compared between the different investigators in order to determine the reproducibility of the investigation. The results will be presented for each criteria as the proportion of concordance between mini and invasive assessment.	Within 30 days from the acquisition of the pCLE videos
Safety of the mini invasive pleural pCLE assessment	Every (Serious)adverse event will be reported during the intervention or during post intervention surveillance (1 hour post intervention).	(Serious) adverse event will be recorded during the mini invasive and invasive assessment and until one hour post procedure.

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Study Director: Duysinx Bernard, PhD, University of Liège

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Probe based confocal laser endomicroscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Diseases; Pleural Neoplasms
• Other Study ID Numbers: 2018-192

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