CELLVICROHN: Cellvizio to Evaluate Margins in Crohn's Ileal Disease

Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cellvizio

Study Design

Study Type:
Anticipated Enrollment :
41 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
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
Actual Study Start Date :
Mar 3, 2022
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 CHU Amiens Picardie Amiens France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • PI2022_843_0111
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2023