Cellvizio to Evaluate Margins in Crohn's Ileal Disease

Not Applicable

Recruiting

• Conditions: Resection Margins; Crohn Disease; Recurrence
• Interventions: Procedure: cellvizio

• Registration Number: NCT05805020
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-03
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cellvizio	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

Primary Outcome Measures

Name	Time	Method
concordance between the Cellvizio pictures and the pathology incidence	2 years	concordance between the Cellvizio pictures and the pathology for microscopic inflammation at the ileal resection margin.

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France