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Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03805971
Recruitment Status : Completed
First Posted : January 16, 2019
Results First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Olivier Bonhomme, University of Liege

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.

Condition or disease Intervention/treatment
Pleural Carcinomatosis Device: Study of the pleural cavity with a confocal laser endomicroscope.

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.
Actual Study Start Date : May 22, 2018
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
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
Device: 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.




Primary Outcome Measures :
  1. Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. [ Time Frame: One day. ]
    Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table

  2. Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. [ Time Frame: 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


  3. Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. [ Time Frame: 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


  4. Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. [ Time Frame: 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 Outcome Measures :
  1. Quality of the pCLE Acquisition [ Time Frame: One day ]
    The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.


Biospecimen Retention:   None Retained
Pleural biopsies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patient refered for a medical thoracoscopy and willing to participate.
Criteria

Inclusion Criteria:

  • Every patient refered for a medical thoracoscopy and willing to participate.

Exclusion Criteria:

  • < 18 ans

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805971


Locations
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Belgium
CHU de Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Olivier Bonhomme, MD CHU de Liège
  Study Documents (Full-Text)

Documents provided by Olivier Bonhomme, University of Liege:
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Responsible Party: Olivier Bonhomme, Medical doctor - clinical assistant, University of Liege
ClinicalTrials.gov Identifier: NCT03805971    
Other Study ID Numbers: B707201837069
First Posted: January 16, 2019    Key Record Dates
Results First Posted: April 3, 2020
Last Update Posted: April 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olivier Bonhomme, University of Liege:
pCLE
confocal laser endomicroscopy
pleural carcinomatosis
mesothelioma
optical biopsies
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type