Pleural Carcinomatosis
Conditions
Keywords
pCLE, confocal laser endomicroscopy, pleural carcinomatosis, mesothelioma, optical biopsies
Brief summary
Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level (optical biopsies). It was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. In gastroenterology, this new investigational technique is used in Barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. The investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. The pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.
Interventions
DEVICEStudy of the pleural cavity with a confocal laser endomicroscope.
Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.
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 refered for a medical thoracoscopy and willing to participate.
Exclusion criteria
* \< 18 ans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | One day. | Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table |
| Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | One day | Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Here are presented Mean cell size and maximum vascular diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of the pCLE Acquisition | One day | The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Aged More Than 18 Years Admitted for Thoracoscopy Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies
Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Patient Aged More Than 18 Years Admitted for Thoracoscopy | — |
|---|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 17.29 | — |
| Final histological diagnosis Breast adenocarcinoma | 1 Participants | — |
| Final histological diagnosis Chronic pleuritis | 13 Participants | — |
| Final histological diagnosis Large cell lymphoma | 2 Participants | — |
| Final histological diagnosis Malignant mesothelioma | 7 Participants | — |
| Final histological diagnosis Normal pleura | 7 Participants | — |
| Final histological diagnosis Pulmonary adenocarcinoma | 9 Participants | — |
| Final histological diagnosis Sarcoidosi | 1 Participants | — |
| Final histological diagnosis Small cell lung carcinoma | 3 Participants | — |
| Final histological diagnosis Squamous cell lung carcinoma | 3 Participants | — |
| Final histological diagnosis (Sub-)acute pleuritis | 15 Participants | — |
| Final histological diagnosis Urothelial Carcinoma | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 43 Participants | — |
| Thoracoscopy indication Pleural exudation management (mainly lymphocytic) | 46 Participants | — |
| Thoracoscopy indication Pleural hyper metabolism on TEP | 2 Participants | — |
| Thoracoscopy indication Pleural nodularity on CT-scan | 2 Participants | — |
| Thoracoscopy indication Talc pleurodesis for recurrent malignant effusion | 4 Participants | — |
| Thoracoscopy indication Talc pleurodesis for recurrent pneumothorax | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
Time frame: One day.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Abnormal tissular architecture | Yes | 8 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Abnormal tissular architecture | No | 21 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Abnormal tissular architecture | Not assessable | 7 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular size homogeneity | Yes | 18 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular size homogeneity | No | 14 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular size homogeneity | Not assessable | 4 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular shape homogeneity | Yes | 18 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular shape homogeneity | No | 14 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular shape homogeneity | Not assessable | 4 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular fluorescence homogeneity | Yes | 28 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular fluorescence homogeneity | No | 7 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular fluorescence homogeneity | Not assessable | 1 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Blood vessels dysplasia | Yes | 8 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Blood vessels dysplasia | No | 23 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Blood vessels dysplasia | Not assessable | 5 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Organized connective tissue | Yes | 11 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Organized connective tissue | No | 20 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Organized connective tissue | Not assessable | 5 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Chia seed sign | Yes | 13 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Chia seed sign | No | 23 Participants |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Chia seed sign | Not assessable | 0 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular fluorescence homogeneity | No | 10 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Abnormal tissular architecture | Yes | 24 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Chia seed sign | Yes | 0 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Abnormal tissular architecture | No | 0 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular fluorescence homogeneity | Not assessable | 2 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Abnormal tissular architecture | Not assessable | 2 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Organized connective tissue | No | 12 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular size homogeneity | Yes | 7 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Blood vessels dysplasia | Yes | 17 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular size homogeneity | No | 16 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Chia seed sign | Not assessable | 0 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular size homogeneity | Not assessable | 3 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Blood vessels dysplasia | No | 3 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular shape homogeneity | Yes | 4 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Organized connective tissue | Not assessable | 9 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular shape homogeneity | No | 19 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Blood vessels dysplasia | Not assessable | 6 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular shape homogeneity | Not assessable | 3 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Chia seed sign | No | 26 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Cellular fluorescence homogeneity | Yes | 14 Participants |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. | Organized connective tissue | Yes | 5 Participants |
Comparison: The objective of the test is to assess if the pCLE feature full chia seed sign is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group.p-value: 0.0003Fisher Exact
Comparison: The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the malignant pleural infiltrations group than in the benign pleura group.p-value: <0.0001Fisher Exact
Comparison: The objective is to assess if the pCLE feature cellular shape homogeneity is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group.p-value: 0.0052Fisher Exact
Comparison: The objective is to assess if dysplastic vessels are more frequently found in the malignant pleural infiltrations group than in the benign pleura group.p-value: <0.0001Fisher Exact
Primary
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Here are presented Mean cell size and maximum vascular diameter
Time frame: One day
Population: Some criteria were not assessable for some patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | Mean cell size | 21.76 µm | Standard Deviation 5.69 |
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | Maximal vascular diameter | 22.72 µm | Standard Deviation 9.93 |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | Mean cell size | 22.96 µm | Standard Deviation 5.16 |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | Maximal vascular diameter | 27.08 µm | Standard Deviation 8.91 |
Primary
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Quantitative criteria are presented in this table. Here is presented the mean cellular density
Time frame: One day
Population: Some criteria were not assessable for some patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | 25.42 number of cells/10^4µm^2 | Standard Deviation 8.73 |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | 22.01 number of cells/10^4µm^2 | Standard Deviation 7.35 |
Primary
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Quantitative criteria are presented in this table. Here is presented the vascular density.
Time frame: One day
Population: Some criteria were not assessable for some patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benign Pleura | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | 9.81 Vessels/1.13 mm^2 (full optic area) | Standard Deviation 7.73 |
| Malignant Pleural Infiltrations | Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. | 6.9 Vessels/1.13 mm^2 (full optic area) | Standard Deviation 2.53 |
Secondary
Quality of the pCLE Acquisition
The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.
Time frame: One day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Benign Pleura | Quality of the pCLE Acquisition | Acceptable | 13 Participants |
| Benign Pleura | Quality of the pCLE Acquisition | Low | 11 Participants |
| Benign Pleura | Quality of the pCLE Acquisition | Good | 12 Participants |
| Malignant Pleural Infiltrations | Quality of the pCLE Acquisition | Acceptable | 9 Participants |
| Malignant Pleural Infiltrations | Quality of the pCLE Acquisition | Good | 8 Participants |
| Malignant Pleural Infiltrations | Quality of the pCLE Acquisition | Low | 9 Participants |