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?

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? - CELLVICROHN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003499-18-FR

Enrollment

Registered

2023-01-12

Start date

2023-03-22

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn’s ileal disease

Interventions

Trade Name: FLUOCYNE 10% Product Name: FLUOCYNE 10%, solution for injection I.V.mg/mL Pharmaceutical Form: Solution for injection in vial

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patient = 18 years old Patient with end-stage ileal Crohn's disease (regardless of phenotype) requiring ileocaecal resection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11

Exclusion criteria

Exclusion criteria: - Patients with Crohn's disease operated on urgently for peritonitis - Patient with a contraindication to the injection of fluorescein (allergy to fluorescein, severe allergy to a drug, moderate to severe renal insufficiency, hepatic insufficiency, history of cardiopulmonary disease, diabetes, concomitant treatments (in particular beta-blockers , including beta-blockers in eye drops)).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: Evaluate the interest of Cellvizio with the intravenous injection of fluorescein intraoperatively (concordance with the anatomopathology): - for the study of the ileal serosa for (search for transmural Crohn's disease) - to assess whether or not the resected mesentery is inflammatory Assess the additional bowel length that would need to be resected to be microscopically healthy at the margin. To constitute a video collection of the different healthy and pathological aspects of the hail (mucosa, serosa) but also of the mesentery;Primary end point(s): is the microscopically healthy or inflammatory character of the ileal mucosal section margin for Cellvizio and pathology.;Timepoint(s) of evaluation of this end point: The day of surgery	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: Evaluate the interest of Cellvizio with the intravenous injection of fluorescein intraoperatively (concordance with the anatomopathology): - for the study of the ileal serosa for (search for transmural Crohn's disease) - to assess whether or not the resected mesentery is inflammatory Assess the additional bowel length that would need to be resected to be microscopically healthy at the margin. To constitute a video collection of the different healthy and pathological aspects of the hail (mucosa, serosa) but also of the mesentery;Primary end point(s): is the microscopically healthy or inflammatory character of the ileal mucosal section margin for Cellvizio and pathology.;Timepoint(s) of evaluation of this end point: The day of surgery

—

Secondary

Measure	Time frame
Secondary end point(s): The concordance between the Cellvizio with an intravenous injection of fluorescein and the pathology for the inflammation of the serosa (transmural inflammation) and of the mesentery and the length of ileum (in cm) between the surgical margin and the theorical resection site to be in a non-inflammatory area at the Cellvizio (on the mucosa and on the serosa)..;Timepoint(s) of evaluation of this end point: The day of surgery	—

Measure

Time frame

Secondary end point(s): The concordance between the Cellvizio with an intravenous injection of fluorescein and the pathology for the inflammation of the serosa (transmural inflammation) and of the mesentery and the length of ileum (in cm) between the surgical margin and the theorical resection site to be in a non-inflammatory area at the Cellvizio (on the mucosa and on the serosa)..;Timepoint(s) of evaluation of this end point: The day of surgery

—

Countries

France

Contacts

Public ContactProject Manager

CHU Amiens-Picardie

mattoug.salah@chu-amiens.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026