N/A
N=65
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.
Pleural Carcinomatosis
Bottom Line
View on ClinicalTrials.gov: NCT03805971 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. — 8; 24; 21; 0 Participants — p=0.0003
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Study of the pleural cavity with a confocal laser endomicroscope. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Liege
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. |
8; 24; 21; 0; 7; 2 | 0.0003 sig |
| PRIMARY Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. |
9.81; 6.9 | — |
| PRIMARY Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. |
9.81; 6.9 | — |
| PRIMARY Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria. |
9.81; 6.9 | — |
| SECONDARY Quality of the pCLE Acquisition |
12; 8; 13; 9; 11; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Every patient refered for a medical thoracoscopy and willing to participate.
Exclusion Criteria
- < 18 ans
Data sourced from ClinicalTrials.gov (NCT03805971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.