Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

Completed

Conditions: Pleural Neoplasms
Pleural Diseases

Registration Number: NCT04731129

Lead Sponsor: University of Liege

Brief 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 59

Inclusion Criteria

Every patient referred to the endoscopy unit for medical thoracoscopy

Exclusion Criteria

Pregnancy
Known allergy to the fluorescein

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malignant Pleural Infiltration Identification	one day	Before medical thoracoscopy, the laser endomicroscopy probe will be introduced through the Boutin's needle or the thoracentesis catheter. The pleural probe based confocal laser endomicroscopy acquisition will be assessed by two experienced and unblinded clinicians (aware of the medical history of the patient) during the procedure. The objective is to determine if the preselected criteria are present with significantly different frequencies in malignant adn in benign pleural involvement.
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment.	One day	Every (Serious)adverse event will be reported during the intervention or during post intervention surveillance (1 hour post intervention). The feasibility will be assessed by comparing the images from the mini invasive phase with this from the invasive phase.
Pleural Fluid Cytological Analysis	one day	Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies.