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

Completed

• Conditions: Pleural Carcinomatosis
• Interventions: Device: Study of the pleural cavity with a confocal laser endomicroscope.

• Registration Number: NCT03805971
• Lead Sponsor: 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 pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2019-01-13
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Primary Completion: 2019-10-15
• Study Completion: 2019-12-01
• Results First Submitted: 2019-12-02
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-21
• Last Update Submitted: 2020-03-21
• Results First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

• < 18 ans

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient aged more than 18 years admitted for thoracoscopy	Study of the pleural cavity with a confocal laser endomicroscope.	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

Primary Outcome Measures

Name	Time	Method
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.	One day.	Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.	One day	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium