An observational study in Pleural Diseases and Pleural Neoplasms, sponsored by University of Liege. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by University of Liege · Observational
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.
yes No
Every patient referred to the endoscopy unit for medical thoracoscopy
Exclusion Criteria:
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.
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
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
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
| Milestone | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion |
|---|---|
| Started | 59 |
| Completed | 52 |
| Not completed | 7 |
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.
| Participants | Patietns With a Pleural Biopsy Histology of Benign Disease | Patients With a Malignant Pleural Biopsy Histology |
|---|---|---|
| Abnormal tissular architecture — Yes | 12 | 27 |
| Abnormal tissular architecture — No | 9 | 4 |
| Homogeneous cell size — Yes | 15 | 10 |
| Homogeneous cell size — No | 6 | 21 |
| Homogeneous cell shape — Yes | 15 | 10 |
| Homogeneous cell shape — No | 6 | 21 |
| Homogeneous cell fluorescence — Yes | 11 | 7 |
| Homogeneous cell fluorescence — No | 10 | 24 |
| Blood vessel dysplasia — Yes | 9 | 20 |
| Blood vessel dysplasia — No | 12 | 11 |
| Organized conjunctive fibers — Yes | 19 | 23 |
| Organized conjunctive fibers — No | 2 | 8 |
| Full Chia seed sign — Yes | 6 | 2 |
| Full Chia seed sign — No | 15 | 29 |
| General physician conclusion — Yes | 10 | 27 |
| General physician conclusion — No | 11 | 4 |
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.
| Participants | The Entire Studied Population |
|---|---|
| Abnormal tissular architecture — concordant | 49 |
| Abnormal tissular architecture — non concordant | 3 |
| Homogeneous cell shape — concordant | 50 |
| Homogeneous cell shape — non concordant | 2 |
| Homogeneous cell fluorescence — concordant | 50 |
| Homogeneous cell fluorescence — non concordant | 2 |
| Homogeneous cell size — concordant | 50 |
| Homogeneous cell size — non concordant | 2 |
| Full chia seed sign — concordant | 52 |
| Full chia seed sign — non concordant | 0 |
| General physician conclusion — concordant | 52 |
| General physician conclusion — non concordant | 0 |
Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies.
| Participants | Patietns With a Pleural Biopsy Histology of Benign Disease | Patients With a Malignant Pleural Biopsy Histology |
|---|---|---|
| Benign fluid cytology | 21 | 18 |
| malignant pleural fluid cytology | 0 | 13 |
Collected over One day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| The Entire Studied Population | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion |
|---|---|
| Mean | 67 ± 8.5 |
| Sex: Female, Male(Participants) | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion |
|---|---|
| Female | 24 |
| Male | 28 |
| Race and Ethnicity Not Collected(Participants) | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion |
|---|
| Region of Enrollment(participants) | Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion |
|---|---|
| Belgium | 52 |
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Pleural Neoplasms
University of Liege