NCT05805020 Cellvizio to Evaluate Margins in Crohn's Ileal Disease
| NCT ID | NCT05805020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2022-03-03 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 41 participants in total. It began in 2022-03-03 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05805020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05805020 currently recruiting?
Yes, NCT05805020 is actively recruiting participants. Contact the research team at sabbagh.charles@chu-amiens.fr for enrollment information.
Where is the NCT05805020 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05805020 clinical trial?
NCT05805020 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 41 participants.