Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis
Study Details
Study Description
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:
- 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….)
- Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator
yes no
- Mean cellular size:
Small: < 10µm Moderate: 10 - 20µm Large: > 20µm
- Cellular density (with reference to the Chia seed sign)
Low (lower than the Chia seed sign) Moderate High
- Dysplastic vessels:
Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia
- Vascular density (on a full optical area)
Low: 0 -2 vessels Moderate: 3 - 4 vessels High: > 4 vessels
- Organized or anarchic connective fibers
Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture.
- Chia seed sign on a full optical areal
yes No
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Sensitivity, specificity, positive predictive value and negative predictive value of mini invasive pleural pCLE assessment to identify malignant pleural infiltration. [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.]
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.
Secondary Outcome Measures
- 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) [Within 30 days from the acquisition of the pCLE videos.]
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.
- inter-observator reproducibility of the pCLE interpretation and assessment of the 10 criteria. [Within 30 days from the acquisition of the pCLE videos]
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.
- Safety of the mini invasive pleural pCLE assessment [(Serious) adverse event will be recorded during the mini invasive and invasive assessment and until one hour post procedure.]
Every (Serious)adverse event will be reported during the intervention or during post intervention surveillance (1 hour post intervention).
Eligibility Criteria
Criteria
Inclusion Criteria:
- Every patient referred to the endoscopy unit for medical thoracoscopy
Exclusion Criteria:
-
Pregnancy
-
Known allergy to the fluorescein
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Olivier Bonhomme | Liege | Belgium | 4020 |
Sponsors and Collaborators
- University of Liege
Investigators
- Study Director: Duysinx Bernard, PhD, University of Liege
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-192