Patients subject to endocrine or digestive surgery will have intraoperative pCLE examination. The installation and surgical opening will be performed according to standard protocols. The contrast agent, fluorescein, will be injected intravenously to allow tissue visualization with 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.

Histological examination by pCLE technique preceding the frozen section

pCLE

IV Fluorescein (fluorescent contrast agent) administration

IV fluorescein administration

Mihaela Ignat, MD, PhD

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.

Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study

Assessment of the Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery - a Pilot Study

The diagnosis proposed by the surgeon / investigator in intraoperative setting on the basis of video sequences of pCLE will be compared to frozen section.

The diagnosis proposed by the surgeon / investigator after retrospective review of the intraoperative video sequences of pCLE based on the newly described diagnosis criteria will be compared to frozen section and conventional histology.

Comparison of the surgeon's ability to obtain intraoperative diagnosis relative to that of the pathologist in the same circumstances.

Evaluation of the time required for the practice of pCLE and comparison to the time required for frozen section.

Morbidity rate / mortality specific to the pCLE imaging procedure.

IHU Strasbourg

Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rectal Neoplasms

Cysts

Lesion located above the third sacral vertebra

Lesion located below the third sacral vertebra

Surgical resection of the retrorectal mass

Resection of the retrorectal tumor

Thomas Bardol

Aim of the study :

To evaluate postoperative outcomes of all surgical approach for retrorectal tumors.

Methods :

From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected.

Considering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra.

Short and longterm outcomes were compared between the two groups.

Primary outcome :

90 days postoperative morbidity rate

Retro-rectal tumors are a group of heterogeneous and rare lesions. The actual incidence has been estimated to be approximately one case per 40,000 admissions. It is most often a benign tumor that affects young women and the origin is congenital in 60% of cases. The most common benign lesion is a tailgut cyst. Chordoma is the most common malignant lesion. They are mostly asymptomatic or pauci-symptomatic. This is why their diagnosis is regularly accidentaly after a morphological examination such as an abdominal ultrasound or a CT scan. MRI is the gold standard for determining the structure of the lesion, its origin, its topography, its extension in relation to adjacent organs, parameters that are essential to define the type of surgery and its approach.

When a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. A biopsy is not helpful if there is no suspicion of a degenerate lesion. Usually, lesions located under the third sacral vertebra (S3) are approached by dorsal transsacrococcygeal, perineal or combined approach (abdominal and perineal approach) while those located above S3 the approach is abdominal (laparotomy or laparoscopy). As these lesions are, in the majority of cases, benign, the functional impact of surgery is essential. Based on our experience in minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become our first-line approach regardless of the location of the lesion compared to S3. Our hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory histological results to be obtained while limiting postoperative pain and functional sequelae.

Surgical Approach for Retrorectal Tumors Cohort

Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)

Postoperative morbidity according to Clavien Dindo

Any reoperation linked to surgical resection of the retrorectal tumor

Evaluation of surgical margins according to pathological examination

Conversion to laparotomy in case of mini-invasive approach

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study	NCT02552004	All Surgical Co... Malignant Tumor Inflammatory Di... Benign Tumor	pCLE IV fluorescein ...	18 Years -	IHU Strasbourg
Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study	NCT02552004	All Surgical Co... Malignant Tumor Inflammatory Di... Benign Tumor	pCLE IV fluorescein ...	18 Years -	IHU Strasbourg
Surgical Approach for Retrorectal Tumors Cohort	NCT04757103	Malignant Tumor	Resection of th...	18 Years - 99 Years	University Hospital, Montpellier
Surgical Approach for Retrorectal Tumors Cohort	NCT04757103	Malignant Tumor	Resection of th...	18 Years - 99 Years	University Hospital, Montpellier
Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study	NCT02552004	All Surgical Co... Malignant Tumor Inflammatory Di... Benign Tumor	pCLE IV fluorescein ...	18 Years -	IHU Strasbourg

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