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

Pleural Carcinomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805971
• Other study ID #: B707201837069
• Status: Completed
• Start date: May 22, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 1, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 ans

Related Conditions & MeSH terms

• Carcinoma
• 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.

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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	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