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Taking people in FrancePhase 3

Tests a imaging method to check inflamed bowel edges in Crohn's ileal disease

Tests a microscope imaging tool during surgery in adults with ileal Crohn's disease.

Key facts

Who runs it
Centre Hospitalier Universitaire, Amiens
Where
Amiens Cedex 1, FranceSee the site
Registry title
Cellvizio to Evaluate Margins in Crohn's Ileal Disease
Status
Recruiting
Phase
Phase 3
People taking part
41 people, planned
Started
3 Mar 2022
Planned end
Mar 2026
Type of study
Interventional
Treatments tested
  • cellvizio
Record updated
28 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who need surgery to remove part of the ileum and caecum. Cellvizio is used during the operation to look at the cut edges.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Crohn's disease of any type that needs an ileocaecal resection (removal of the end of the small bowel and the start of the large bowel).
Earlier treatment
People who had an ileocolic resection for a return of Crohn's disease after surgery cannot join.

Main reasons for not taking part

  • Under 18 years old
  • Pregnancy or breastfeeding
  • Ileocolic resection for a return of Crohn's disease after surgery
  • Emergency surgery for peritonitis
  • Cannot have a fluorescein injection, or severe allergy to any drug

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

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

Who cannot take part

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

Where in France

  • Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • CellvizioTreatment being tested

    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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests a imaging method to check inflamed bowel edges in Crohn's ileal diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 May 2025