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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Carcinomatosis
• Intervention / Treatment: Device: Study of the pleural cavity with a confocal laser endomicroscope.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU de Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 ans

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the pCLE Acquisition	The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.	One day

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Olivier Bonhomme, MD, CHU de Liège

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: March 21, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pCLE; confocal laser endomicroscopy; pleural carcinomatosis; mesothelioma; optical biopsies
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: B707201837069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No