Using Cellvizio to assess surgical margins in Crohn's disease
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
This study is testing if a special imaging tool called Cellvizio can help surgeons see hidden inflammation during surgery for Crohn's disease, so they can make better decisions about how much tissue to remove and reduce the chances of problems later on.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05805020 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Cellvizio, a technology that allows for real-time imaging during surgery, to assess the microscopic inflammation at resection margins in patients undergoing ileocaecal resection for Crohn's disease. The goal is to determine if this imaging can help surgeons make more informed decisions about the extent of resection needed to minimize the risk of postoperative recurrence. By identifying inflammation that may not be visible to the naked eye, the study aims to improve surgical outcomes for patients with Crohn's disease.
Who should consider this trial
Good fit: Ideal candidates for this study are patients requiring ileocaecal resection for Crohn's disease, regardless of the disease phenotype.
Not a fit: Patients under 18 years old, pregnant or breastfeeding, or those with specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of recurrence in Crohn's disease patients after surgery.
How similar studies have performed: While the use of real-time imaging in surgical settings is gaining interest, this specific application in Crohn's disease resection margins is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens
- CHU Amiens Picardie — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Charles Sabbagh, Pr
- Email: sabbagh.charles@chu-amiens.fr
- Phone: 03 22 08 88 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.