An interventional study of Confocal Laser Endomicroscopy in Hepatocarcinoma, Hepatic Metastasis and Hepatic Tumor, sponsored by Mauna Kea Technologies. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-24.
Sponsored by Mauna Kea Technologies · Not applicable, Interventional, and Other
This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.
Colorectal cancer is the third most common cancer and third leading cause of cancer deaths in the Western countries. In France, 45.000 new patients develop colorectal cancer every year. The liver is the most common organ targeted by CRLM, representing 50%. Approximately, 15-25% of colorectal cancer patients have synchronous CRLM at initial workup, and 20-30% patients sustain subsequent liver metastases within few years following diagnosis.
The strategy for colorectal cancer liver metastasis resection and liver cancer has evolved to a parenchymatic sparing procedure. This technic aims to minimize surgical margins width while removing the tumor. Therefore, the current standard for resection margins is a margin width superior to 1mm. However, there is still a debate concerning the margin width. Indeed, with modern chemotherapy, several studies reported no statistical differences in the overall survival between R0 patients and R1 patients treated with chemotherapy. However, in order to preserve patients from chemotherapy treatments' adverse effects an intra-operative microscopic assessment of surgical margins should be set up in order to reduce R1 margins occurrence.
Ex vivo study:
Surgical specimens obtained during hepatectomy will be imaged to generate an atlas of pCLE images.
In vivo study:
Intraoperative characterization of sub-capsular hepatic masses and surgical margins will be assessed.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 40 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Mauna Kea Technologies is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
lt includes patients will undergo probe-based Confocal Laser Endomicroscopy during laparoscopic hepatic masses resection.
Device: Confocal Laser Endomicroscopy
The study is divided in two parts. For the two parts, patients will receive an intravenous injection of indocyanine green: 1. Ex vivo study - Images/sequences of normal and abnormal hepatic tissues and surgical margins will be acquired on surgical specimens 2. In vivo study - Intra-operative pCLE imaging will be performed on hepatic masses and surgical margins
Also known as: probe-based Confocal Laser Endomicroscopy, CelioFlex UHD 5 probe, Viziobot-P, GastroFlex UHD probe, Cellvizio 100 series, pCLE, Confocal Miniprobes
malignant pCLE criteria
Definition of pCLE criteria for normal and malignant hepatic tissues
Time frame: 1 year
pathological pCLE criteria
Definition of pCLE criteria for pathological hepatic parenchyma (non tumoral)
Time frame: 1 year
Ease of use of the endomicroscopy device
The ease of use of the endomicroscopy device will be assessed using a questionnaire that the surgeon will fill at the end of each procedure
Time frame: 1 year
Audio/video telecommunication quality
The telecommunication quality will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure
Time frame: 1 year
Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0
The device safety will be measured by assessing the occurence and severity of adverse events during the study
Time frame: 1 year
Stability and reproducibility of images/sequences during procedures
The stability and reproducibility of endomicroscopy images will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure
Time frame: 1 year
pCLE criteria diagnostic performance
The diagnostic performance of identified pCLE criteria will be expressed by their sensitivities, specificities, negative predictive value and positive predictive value.
Time frame: 1 year
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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