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

NCT03805971 | Completed Results

• 1 other identifier: B707201837069
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Carcinomatosis

Keywords

pCLE; confocal laser endomicroscopy; pleural carcinomatosis; mesothelioma; optical biopsies

Outcome Measures

Primary Outcomes (4)

• Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.

  Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table

  One day.

• Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.

  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

  One day

• Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.

  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

  One day

• Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.

  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.

  One day

Secondary Outcomes (1)

• Quality of the pCLE Acquisition

  One day

Study Arms (1)

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.

Interventions

Study of the pleural cavity with a confocal laser endomicroscope. DEVICE

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.

patient aged more than 18 years admitted for thoracoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \< 18 ans

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: NONE RETAINED

Pleural biopsies.

MeSH Terms

Conditions

Mesothelioma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Results Point of Contact

• Title: Dr Olivier Bonhomme
• Organization: Centre hospitalier universitaire de Liège

obonhomme@chuliege.be

003243667881

Study Officials

• Olivier Bonhomme, MD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor - clinical assistant

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: January 16, 2019
• Study Start: May 22, 2018
• Primary Completion: October 15, 2019
• Study Completion: December 1, 2019
• Last Updated: April 3, 2020
• Results First Posted: April 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)