Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

Status Completed

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04731129
Study type	Observational
Source	University of Liege
Contact
Status	Completed
Phase
Start date	December 15, 2020
Completion date	November 30, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.