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Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Carcinomatosis Diagnosis

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ClinicalTrials.gov Identifier: NCT03805971
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : February 21, 2019
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 investigators Compared endomicroscopy diagnosis and pathologic diagnosis to assess the ability of this new tool to diagnose a pleural carcinomatosis.

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
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Carcinomatosis Diagnosis
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 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) [ Time Frame: One day. ]
    Ability of confocal endomicroscopy to identify pleural carcinomatosis with comparison to standard histological studies.


Biospecimen Retention:   None Retained
Pleural biopsies.


Information from the National Library of Medicine

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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


Contacts
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Contact: Olivier Bonhomme, MD 003243667881 obonhomme@chuliege.be
Contact: Bernard Duysinx, PhD 003243667881 bduysinx@chuliege.be

Locations
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Belgium
CHU de Liège Recruiting
Liège, Belgium, 4000
Contact: Olivier Bonhomme, MD         
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Olivier Bonhomme, MD CHU de Liège

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Responsible Party: Olivier Bonhomme, Medical doctor - clinical assistant, University of Liege
ClinicalTrials.gov Identifier: NCT03805971     History of Changes
Other Study ID Numbers: B707201837069
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
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, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms