NCT03805971 · REGISTRY CONDITION SEARCH
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- COMPLETED
- Registry last update
- 2020-04-03
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Quality of the pCLE Acquisition
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Every patient refered for a medical thoracoscopy and willing to participate. Exclusion Criteria: * \< 18 ans
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Every patient refered for a medical thoracoscopy and willing to participate.
Treatment arms and interventions
- arm Groups
- description
- 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
- intervention Names
- Device: Study of the pleural cavity with a confocal laser endomicroscope.
- label
- patient aged more than 18 years admitted for thoracoscopy
- interventions
- arm Group Labels
- patient aged more than 18 years admitted for thoracoscopy
- description
- 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.
- name
- Study of the pleural cavity with a confocal laser endomicroscope.
- type
- DEVICE
Study design
- observational Model
- CASE_ONLY
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 65
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
- measure
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
- time Frame
- One day.
- description
- 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
- measure
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
- time Frame
- One day
- description
- 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
- measure
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
- time Frame
- One day
- description
- 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.
- measure
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
- time Frame
- One day
- secondary Outcomes
- description
- The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.
- measure
- Quality of the pCLE Acquisition
- time Frame
- One day
Full study description
- 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.
Source references
- references
- citation
- 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
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice
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