Cellvizio to Evaluate Margins in Crohn's Ileal Disease (CELLVICROHN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Crohn Disease; Resection Margins
• Intervention / Treatment: Procedure: cellvizio

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Sabbagh, Pr; Phone Number: 03 22 08 88 96; Email: sabbagh.charles@chu-amiens.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
    • Contact: Charles Sabbagh, Pr; Phone Number: 03 22 08 88 96; Email: sabbagh.charles@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who need a ileocaecal resection for a Crohn disease whatever is the phenotype of the Crohn's disease

Exclusion Criteria:

• Patients<18 years old,
• pregnancy or breastfeeding,
• patients who have an ileocolic resection for a surgical recurrence of the Crohn's disease.
• Patients operated in emergency for a peritonitis,
• patients who have a contra-indication for fluorescein injection or severe allergia to any drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cellvizio; 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

Procedure: cellvizio; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance between the Cellvizio pictures and the pathology incidence	concordance between the Cellvizio pictures and the pathology for microscopic inflammation at the ileal resection margin.	2 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: recurrence; Crohn Disease; Resection Margins
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Recurrence; Crohn Disease; Ileal Diseases
• Other Study ID Numbers: PI2022_843_0111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No