Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| All Surgical Conditions Usually Necessitating Frozen Section | — | UNRESOLVED | — |
| Benign Tumor | Benign Neoplasm | ALIAS | 0.90 |
| Inflammatory Disease | — | UNRESOLVED | — |
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV fluorescein administration | Drug | — | UNRESOLVED |
| pCLE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pCLE
- description
- 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.
- interventionNames
- Device: pCLE
- Drug: IV fluorescein administration
Primary outcomes (1)
- measure
- Diagnosis accuracy of intraoperative imaging with pCLE technique
- timeFrame
- During surgery
- description
- The diagnosis proposed by the surgeon / investigator in intraoperative setting on the basis of video sequences of pCLE will be compared to frozen section.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDWallace MB, Fockens P. Probe-based confocal laser endomicroscopy. Gastroenterology. 2009 May;136(5):1509-13. doi: 10.1053/j.gastro.2009.03.034. Epub 2009 Mar 28. No abstract available. PMID 19328799
- BACKGROUNDIgnat M, Aprahamian M, Lindner V, Altmeyer A, Perretta S, Dallemagne B, Mutter D, Marescaux J. Feasibility and reliability of pancreatic cancer staging using fiberoptic confocal fluorescence microscopy in rats. Gastroenterology. 2009 Nov;137(5):1584-92.e1. doi: 10.1053/j.gastro.2009.07.045. Epub 2009 Jul 24. PMID 19632230
- BACKGROUNDKwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006 Jan-Feb;34(1):33-8. doi: 10.1111/j.1442-9071.2006.01136.x. PMID 16451256
- RESULTIgnat M, Lindner V, Vix M, Marescaux J, Mutter D. Intraoperative Probe-Based Confocal Endomicroscopy to Histologically Differentiate Thyroid From Parathyroid Tissue Before Resection. Surg Innov. 2019 Apr;26(2):141-148. doi: 10.1177/1553350618814078. Epub 2018 Nov 23. PMID 30466375