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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

Tracking Information
First Submitted Date January 13, 2019
First Posted Date January 16, 2019
Last Update Posted Date February 21, 2019
Actual Study Start Date May 22, 2018
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03805971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Carcinomatosis Diagnosis
Official Title Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Carcinomatosis Diagnosis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Pleural biopsies.
Sampling Method Non-Probability Sample
Study Population Every patient refered for a medical thoracoscopy and willing to participate.
Condition Pleural Carcinomatosis
Intervention 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.
Study Groups/Cohorts 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
Intervention: Device: Study of the pleural cavity with a confocal laser endomicroscope.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 15, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2019
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • < 18 ans
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Olivier Bonhomme, MD 003243667881 obonhomme@chuliege.be
Contact: Bernard Duysinx, PhD 003243667881 bduysinx@chuliege.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03805971
Other Study ID Numbers B707201837069
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Olivier Bonhomme, University of Liege
Study Sponsor University of Liege
Collaborators Not Provided
Investigators
Principal Investigator: Olivier Bonhomme, MD CHU de Liège
PRS Account University of Liege
Verification Date February 2019