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

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IHU Strasbourg

Criteria

Inclusion Criteria:

• Patient, male or female, over 18 years old

• Patient candidate to digestive or endocrine surgery in whom the surgeon deems necessary intraoperative frozen section

• Patient able to understand the study and to provide informed consent

• Patient affiliated to the French social security system

Exclusion Criteria:

• Patient unable to provide informed consent

• Patient with known or suspected allergy to fluorescein

• Patient who had a previous life-threatening reaction during an angiography

• Patient with a history of multiple and severe allergic reactions to medications

• Patient taking a beta-blocker treatment

• Patient with comorbidity considered by the investigator, as incompatible with the procedures of the study

• Patient pregnant or breastfeeding

• Patient in exclusion period (determined by a previous study or in progress)

• Patient having forfeited their freedom of an administrative or legal obligation

• Patient under guardianship