Inflammatory Disease Clinical Trial
Official title:
Assessment of the Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery - a Pilot Study
Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. The objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the video sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images. The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.
Intraoperative histological examination is a fundamental tool for cancer surgery (extent of
surgery, resection margins, sentinel lymph node) and necessary in other circumstances like
redo surgery or endocrine surgery. Using conventional frozen section technique results in the
prolongation of operating time of about 40 minutes.
Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables
real-time, microscope-resolution imaging. Specifically, after intravenous injection of a
fluorescent contrast agent - in this study fluorescein will be used, the pCLE system provides
video sequences of the tissue, using a confocal microscope integrated in a miniprobe and a
low power laser as the illumination source (Cellvizio®, Mauna Kea Technologies, Paris,
France).
The pCLE is currently used in endoscopy, mainly for the follow-up of Barrett's esophagus,
colorectal polyps and strictures of the bile and pancreatic ducts, but also in urology. The
pCLE has never been tested in open or video-assisted surgery settings. Sterilizable probes
exist and are certified for use via an endoscope in France (UHD CystoFlexTM, AQ-FLEX 19TM
Mauna Kea Technologies, Paris, France). A probe (CelioFlex UHDTM) is currently being
developed for use in laparoscopic surgery setting.
This pilot study aims to evaluate pCLE in surgical setting. Each anatomical structure
corresponds to a specific tissue architecture, which is today known through standard
histological examination. Conventional histology implies alteration of the tissue
architecture, with ablation of blood supply, sampling and technical treatment of the samples
(fixation, cutting, staining). The pCLE enables to bypass this process and allows obtaining
images of the microscopic structure in vivo, without cell damage and without interruption of
the blood and lymphatic circulation. The obtained video sequences reflect the microscopic
architecture, in a form which is to date, neither mapped nor exploited for deep organs. The
potential of this technique was demonstrated in intraabdominal organs only in the animal
model, with very encouraging results as the sensitivity and specificity of pCLE were superior
to standard histological examination.
The primary objective is the depiction of histological rendering of normal and pathological
tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical
conditions usually necessitating frozen section will be investigated. A total of 30 patients,
with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal,
colon / small intestine, liver will be included.
The installation and surgical opening will be performed according to standard protocols. A
contrast agent, fluorescein, will be injected intravenously to allow tissue visualization
with the pCLE. During the surgery, the surgeon will perform the pCLE examination, to obtain
and record video sequences of in situ structures. Frozen sections will be obtained on the
same samples and will further guide the surgical decision-making.
Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by
retrospective analysis of the sequences in comparison to conventional histology slides. The
data will be used to create an image bank of reference optical biopsy images.
The study will allow to point out the surgical conditions in which pCLE is the most effective
and reliable and could eventually replace the frozen section technique.
A second study, in comparative prospective settings, could further be focused only on the
promising conditions in order to evaluate diagnosis accuracy on a statistical basis.
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