Skip to main content
OpenTrials
Completed

NCT Number: NCT03805971

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • < 18 ans

Treatment and study plan

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.

Primary outcomes

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

    Time frame: One day.

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

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

    Time frame: One day

    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

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

    Time frame: 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 mean cellular density

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

    Time frame: 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 outcomes

  1. Quality of the pCLE Acquisition

    Time frame: One day

    The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.