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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probe based confocal laser endomicroscopy of the pleura | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Malignant Pleural Infiltration Identification | 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. | one day |
| Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | 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. | One day |
| Pleural Fluid Cytological Analysis | Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies. | one day |
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Inclusion Criteria:
Exclusion Criteria:
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Every patient referred to the endoscopy unit for medical thoracoscopy
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| Name | Affiliation | Role |
|---|---|---|
| Duysinx Bernard, PhD | University of Liege | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olivier Bonhomme | Liège | 4020 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion | Every patient referred to medical thoracoscopy for pleural effusion treatment or workup. exclusion criteria are age< 18; Pregnancy; Known allergy to fluorescein |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion | Every patient referred to medical thoracoscopy for pleural effusion treatment or workup. exclusion criteria are age< 18; Pregnancy; Known allergy to fluorescein |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 8 patients unwilling to participate |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Malignant Pleural Infiltration Identification | 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. | Posted | Count of Participants | Participants | one day |
|
One day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Entire Studied Population | Every patient included had pleural biopsies at the end of the medical thoracoscopy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Olivier Bonhomme | Centre hospitalier universitaire de liège | 003243239580 | obonhomme@chuliege.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2020 | Nov 22, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2020 | Sep 24, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D010997 | Pleural Neoplasms |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients With a Malignant Pleural Biopsy Histology |
Every patient included had pleural biopsies at the end of the medical thoracoscopy. This group gathers patients with a malignant pleural effusion according to pleural biopsies. |
|
|
|
| Primary | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | 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. | Posted | Count of Participants | Participants | One day |
|
|
|
| Primary | Pleural Fluid Cytological Analysis | Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies. | Posted | Count of Participants | Participants | one day |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
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| D009369 | Neoplasms |
| non concordant |
|
| Homogeneous cell fluorescence |
|
| Homogeneous cell size |
|
| Full chia seed sign |
|
| General physician conclusion |
|