Pleural Diseases, Pleural Neoplasms
Conditions
Keywords
Probe based confocal laser endomicroscopy
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
Interventions
DEVICEProbe based confocal laser endomicroscopy of the pleura
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.
Sponsors
University of Liege
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Every patient referred to the endoscopy unit for medical thoracoscopy
Exclusion criteria
* Pregnancy * Known allergy to the fluorescein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pleural Fluid Cytological Analysis | one day | Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies. |
| 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion | — |
|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 8.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 52 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
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.
Time frame: One day
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Abnormal tissular architecture | concordant | 49 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Abnormal tissular architecture | non concordant | 3 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Homogeneous cell shape | concordant | 50 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Homogeneous cell shape | non concordant | 2 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Homogeneous cell fluorescence | concordant | 50 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Homogeneous cell fluorescence | non concordant | 2 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Homogeneous cell size | concordant | 50 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Homogeneous cell size | non concordant | 2 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Full chia seed sign | concordant | 52 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | Full chia seed sign | non concordant | 0 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | General physician conclusion | concordant | 52 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. | General physician conclusion | non concordant | 0 Participants |
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.
Time frame: one day
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Abnormal tissular architecture | Yes | 12 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Abnormal tissular architecture | No | 9 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Homogeneous cell size | Yes | 15 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Homogeneous cell size | No | 6 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Homogeneous cell shape | Yes | 15 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Homogeneous cell shape | No | 6 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Homogeneous cell fluorescence | Yes | 11 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Homogeneous cell fluorescence | No | 10 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Blood vessel dysplasia | Yes | 9 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Blood vessel dysplasia | No | 12 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Organized conjunctive fibers | Yes | 19 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Organized conjunctive fibers | No | 2 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Full Chia seed sign | Yes | 6 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | Full Chia seed sign | No | 15 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | General physician conclusion | Yes | 10 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Malignant Pleural Infiltration Identification | General physician conclusion | No | 11 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | General physician conclusion | No | 4 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Abnormal tissular architecture | Yes | 27 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Blood vessel dysplasia | Yes | 20 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Abnormal tissular architecture | No | 4 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Full Chia seed sign | Yes | 2 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Homogeneous cell size | Yes | 10 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Blood vessel dysplasia | No | 11 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Homogeneous cell size | No | 21 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | General physician conclusion | Yes | 27 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Homogeneous cell shape | Yes | 10 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Organized conjunctive fibers | Yes | 23 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Homogeneous cell shape | No | 21 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Full Chia seed sign | No | 29 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Homogeneous cell fluorescence | Yes | 7 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Organized conjunctive fibers | No | 8 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Malignant Pleural Infiltration Identification | Homogeneous cell fluorescence | No | 24 Participants |
Comparison: Abnormal tissular architecturep-value: 0.023Fisher Exact
Comparison: Homogeneous cell sizep-value: 0.01Fisher Exact
Comparison: Homogeneous cell shapep-value: 0.01Fisher Exact
Comparison: Homogeneous cell fluorescencep-value: 0.013Fisher Exact
Comparison: Blood vessel dysplasiap-value: 0.16Fisher Exact
Comparison: Organized conjunctive fibersp-value: 0.17Fisher Exact
Comparison: Full chia seed signp-value: 0.049Fisher Exact
Comparison: General physician conclusionp-value: 0.0041Fisher Exact
Primary
Pleural Fluid Cytological Analysis
Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies.
Time frame: one day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patietns With a Pleural Biopsy Histology of Benign Disease | Pleural Fluid Cytological Analysis | Benign fluid cytology | 21 Participants |
| Patietns With a Pleural Biopsy Histology of Benign Disease | Pleural Fluid Cytological Analysis | malignant pleural fluid cytology | 0 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Pleural Fluid Cytological Analysis | Benign fluid cytology | 18 Participants |
| Patients With a Malignant Pleural Biopsy Histology | Pleural Fluid Cytological Analysis | malignant pleural fluid cytology | 13 Participants |