Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

Pleural Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731129
• Other study ID #: 2018-192
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Every patient referred to the endoscopy unit for medical thoracoscopy

Exclusion Criteria:

• Pregnancy

• Known allergy to the fluorescein

Related Conditions & MeSH terms

• Pleural Diseases
• Pleural Neoplasms

Intervention

Device:
• Probe based confocal laser endomicroscopy of the pleura
Every patient referred for medical thoracoscopy will be screened. The pCLE of the pleura will be performed 2 times. First, just before the thoracoscopy, through the Boutin's needle or the thoracentesis catheter and second through the working chanel of the pleuroscope. This last acquisition allows visual control to target the pleural endomicroscopy assessment. These two acquisitions will be compared between each other and with the histological samples of the pleuroscopy.

Locations

Country	Name	City	State
Belgium	Olivier Bonhomme	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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.