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Cellvizio to Evaluate Margins in Crohn's Ileal Disease (CELLVICROHN)

Primary Purpose

Crohn Disease, Resection Margins, Recurrence

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cellvizio
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn Disease focused on measuring Crohn Disease, Resection Margins, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Amiens PicardieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cellvizio

Arm Description

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

Outcomes

Primary Outcome Measures

concordance between the Cellvizio pictures and the pathology incidence
concordance between the Cellvizio pictures and the pathology for microscopic inflammation at the ileal resection margin.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
April 26, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05805020
Brief Title
Cellvizio to Evaluate Margins in Crohn's Ileal Disease
Acronym
CELLVICROHN
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Resection Margins, Recurrence
Keywords
Crohn Disease, Resection Margins, recurrence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cellvizio
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
cellvizio
Intervention Description
During surgery an intravenous injection of fluorescein will be performed. The surgeon will, then, evaluate the ileal section margins on the mucosa, the serosa and the mesentery to evaluate if the section margin in microscopically inflammatory or not. She/he will then evaluate (in cm) the length between this section margin and the theorical section margin to be on a non-inflammatory tissue on the mucosa, serosa and mesentery. The data will be filled during surgery, blind from the pathological analysis. The pathological analysis will also be blind from the Cellvizio data. A video collection will be performed anonymously.
Primary Outcome Measure Information:
Title
concordance between the Cellvizio pictures and the pathology incidence
Description
concordance between the Cellvizio pictures and the pathology for microscopic inflammation at the ileal resection margin.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Sabbagh, Pr
Phone
03 22 08 88 96
Email
sabbagh.charles@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Sabbagh, Pr
Phone
03 22 08 88 96
Email
sabbagh.charles@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cellvizio to Evaluate Margins in Crohn's Ileal Disease

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