RecruitingNot ApplicableNCT05805020

Cellvizio to Evaluate Margins in Crohn's Ileal Disease

Is There a Concordance Between the Cellvizio With an Intravenous Injection of Fluorescein and the Pathology to Determine the Microscopic Inflammation at the Ileal Resection Margins in Crohn's Ileal Disease


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

41 participants

Start Date

Mar 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Crohn disease is an inflammatory bowel disease. A surgical procedure is required in about 80% of cases. Surgery doesn't cure from Crohn's disease but the type of surgery remains important as there are several intraoperative risk factors for recurrence. Among these factors the microscopic inflammation at the resection margins. This is a crucial point, if the resection is too large there is a risk of short bowel syndrome, if the resection is too short (microscopic inflammation at resection site), there is a higher risk of postoperative recurrence (75% vs 46% at 18 months). Surgeons have to do a limited resection (2cm from macroscopic crohn disease). However this macroscopic non inflammatory resection margin can be microscopically inflammatory (up to 80%). Thus it is useful to evaluate if there is a microscopic inflammation at the resection margin. Moreover there is an increase interest for the role of the mesentery for recurrence but its role remains unclear. It is of interest to clarify the border between the inflammatory and non-inflammatory mesentery. Cellvizio is a confocal laser endomicroscopy providing the possibility of obtaining in vivo high-magnification images of the gut epithelium. This allows real-time examination of the gastrointestinal mucosa at the cellular and subcellular level. Cellvizio has never been used during surgery for Crohn disease. The aim of this study is to evaluate the intraoperative use of Cellvizio (using the CelioFlex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in Crohn disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a specialized imaging technique using a probe (confocal laser endomicroscopy) during bowel surgery can help surgeons more accurately determine the boundaries of diseased tissue in patients with Crohn's disease — potentially reducing the chance of the disease coming back after surgery. **You may be eligible if:** - You have Crohn's disease and need surgery to remove the end of your small bowel and part of your large bowel (ileocaecal resection), regardless of your Crohn's disease type **You may NOT be eligible if:** - You are under 18 years old - You are pregnant or breastfeeding - You are having surgery because Crohn's disease came back after a previous bowel resection - You are having emergency surgery for a serious infection (peritonitis) - You have a known allergy to fluorescein (the imaging dye used in the procedure) or a severe allergy to any medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREcellvizio

During surgery an intravenous injection of fluorescein will be performed. The surgeon will, then, evaluate the ileal section margins on the mucosa, the serosa and the mesentery to evaluate if the section margin in microscopically inflammatory or not. She/he will then evaluate (in cm) the length between this section margin and the theorical section margin to be on a non-inflammatory tissue on the mucosa, serosa and mesentery. The data will be filled during surgery, blind from the pathological analysis. The pathological analysis will also be blind from the Cellvizio data. A video collection will be performed anonymously.


Locations(1)

CHU Amiens Picardie

Amiens, France

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NCT05805020


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