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All trials for Pleural Carcinomatosis All trials of Study of the pleural cavity with a confocal laser endomicroscope.
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| patient aged more than 18 years admitted for thoracoscopy | | Device: Study of the pleural cavity with a confocal laser endomicroscope. | 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. (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.
+Outcome measures
Primary outcomes
- 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
- 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.
Quantitative criteria are presented in this table. Here is presented the mean cellular density
- 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.
Quantitative criteria are presented in this table. Here is presented the vascular density.
Secondary outcomes
- 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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Every patient refered for a medical thoracoscopy and willing to participate.
Exclusion Criteria:
* < 18 ans
+Posted results
Participant flow
| Milestone | Patient Aged More Than 18 Years Admitted for Thoracoscopy |
|---|
| Started | 65 |
| Completed | 62 |
| Not completed | 3 |
Outcome results
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. (Primary), Count of participants, Participants: Benign Pleura 8; Malignant Pleural Infiltrations 24 (p 0.0003)
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. (Primary), Mean, µm: Benign Pleura 21.76 +/- 5.69; Malignant Pleural Infiltrations 22.96 +/- 5.16
- Quality of the pCLE Acquisition (Secondary), Count of participants, Participants: Benign Pleura 12; Malignant Pleural Infiltrations 8
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. (Primary), Mean, number of cells/10^4µm^2: Benign Pleura 25.42 +/- 8.73; Malignant Pleural Infiltrations 22.01 +/- 7.35
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. (Primary), Mean, Vessels/1.13 mm^2 (full optic area): Benign Pleura 9.81 +/- 7.73; Malignant Pleural Infiltrations 6.9 +/- 2.53
Adverse events
Time frame: 1 day
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Patient Aged More Than 18 Years Admitted for Thoracoscopy | 0/62 (0.0%) | 0/62 (0.0%) | 0/62 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| CHU de Liège | Liège | Belgium | |
+Publications
- Results publication: 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. PMID 33001538
+Study documents
+Investigators