CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
Probe based confocal laser endomicroscopy of the pleuradevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04731129
NCT04731129N/ACompleted

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

University of Liege·observational·Posted Jan 29, 2021·Updated Jan 10, 2025

In Brief

An observational study evaluating Probe based confocal laser endomicroscopy of the pleura for Pleural Diseases and Pleural Neoplasms. Completed, enrolled 59 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 29, 2021
Enrollment StartDec 15, 2020
Primary CompletionSep 15, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.4 years ago

Interventions

Probe based confocal laser endomicroscopy of the pleuradevice

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.