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

NCT02552004 | Completed

• 1 other identifier: 15-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

All Surgical Conditions Usually Necessitating Frozen Section; Malignant Tumor; Inflammatory Disease; Benign Tumor

Keywords

pCLE; Digestive surgery; Endocrine surgery

Outcome Measures

Primary Outcomes (1)

• Diagnosis accuracy of intraoperative imaging with pCLE technique

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

  During surgery

Secondary Outcomes (4)

• Diagnosis accuracy of pCLE imaging, retrospectively using the newly described diagnosis criteria

  One year

• pCLE video sequences interpretation learning curve

  One year

• Time needed for pCLE imaging procedure

  During surgery

• Specific morbidity and mortality rate

  One month after surgery

Study Arms (1)

pCLE

EXPERIMENTAL

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.

Device: pCLE; Drug: IV fluorescein administration

Interventions

pCLE DEVICE

Histological examination by pCLE technique preceding the frozen section

pCLE

IV fluorescein administration DRUG

IV Fluorescein (fluorescent contrast agent) administration

pCLE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Related Publications (4)

• Wallace 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 BACKGROUND

• Ignat 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 BACKGROUND

• Kwan 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 BACKGROUND

• Ignat 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 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mihaela Ignat, MD, PhD

  Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 16, 2015
• Study Start: October 13, 2015
• Primary Completion: December 14, 2017
• Study Completion: February 1, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

FR (1)