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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.

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
  1. ADULT
  2. OLDER_ADULT
study Population
Every patient refered for a medical thoracoscopy and willing to participate.
Treatment arms and interventions
arm Groups
  1. 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
    1. Device: Study of the pleural cavity with a confocal laser endomicroscope.
    label
    patient aged more than 18 years admitted for thoracoscopy
interventions
  1. arm Group Labels
    1. 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
  1. 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.
  2. 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
  3. 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
  4. 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
  1. 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
  1. 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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      query cond
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    Preserved source evidence · Not medical advice