Cellvizio to Evaluate Margins in Crohn's Ileal Disease

NCT05805020 | Recruiting

• 1 other identifier: PI2022_843_0111
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Resection Margins; Recurrence

Keywords

Crohn Disease; Resection Margins; recurrence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cellvizio

EXPERIMENTAL

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

Interventions

cellvizio PROCEDURE

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.

Cellvizio

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Margins of Excision; Recurrence

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Central Study Contacts

Charles Sabbagh, Pr

CONTACT

03 22 08 88 96; sabbagh.charles@chu-amiens.fr

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: March 28, 2023
• First Posted: April 7, 2023
• Study Start: March 3, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)