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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study of the pleural cavity with a confocal laser endomicroscope. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One day. |
| 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 | One day |
| 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 | One day |
| 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. | One day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One day |
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Inclusion Criteria:
Exclusion Criteria:
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Every patient refered for a medical thoracoscopy and willing to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Bonhomme, MD | Centre Hospitalier Universitaire de Liege | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33001538 | Derived | Bonhomme O, Heinen V, Detrembleur N, Corhay JL, Louis R, Duysinx B. Probe-based confocal laser endomicroscopy for pleural malignancies diagnosis. Respirology. 2021 Feb;26(2):188-195. doi: 10.1111/resp.13945. Epub 2020 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | Posted | Count of Participants | Participants | One day. |
|
1 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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Olivier Bonhomme | Centre hospitalier universitaire de Liège | 003243667881 | 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 | Dec 2, 2019 | Feb 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Pleural biopsies.
| years |
|
| Sex: Female, Male | Gender ratio | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Thoracoscopy indication | Count of Participants | Participants |
|
| Final histological diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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 | Some criteria were not assessable for some patients. | Posted | Mean | Standard Deviation | µm | One day |
|
|
|
| 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. | Posted | Count of Participants | Participants | One day |
|
|
|
| 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 | Some criteria were not assessable for some patients. | Posted | Mean | Standard Deviation | number of cells/10^4µm^2 | One day |
|
|
|
| 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. | Some criteria were not assessable for some patients. | Posted | Mean | Standard Deviation | Vessels/1.13 mm^2 (full optic area) | One day |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
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| D018301 |
| Neoplasms, Mesothelial |
| Not assessable |
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| Not assessable |
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| Not assessable |
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| Not assessable |
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| Not assessable |
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| Not assessable |
|
| Maximal vascular diameter |
|
|
| Low |
|