Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study (MRI-CROHN)
Primary Purpose
Crohn's Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI enterography
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- patients with Crohn's disease
- patients with ileocolonic resection more than 6 months ago and less than 4 years ago
- patients with indication of ileocolonoscopy
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Exclusion Criteria:
- patients with contraindications for MRI
Sites / Locations
- Chu de ReimsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
Patient's with Crohn's disease who have had ileocolic resection
Outcomes
Primary Outcome Measures
recurrence at the anastomosis site and in the ileum
Recurrence diagnosed with colonoscopy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02867540
Brief Title
Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study
Acronym
MRI-CROHN
Official Title
Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief Summary
Nearly three-quarters of patients with Crohn's disease have small bowel involvement and 80% of them will have complications that will require a surgical procedure, usually an ileocolonic resection with ileocolonic anastomosis. The rate of recurrence at the anastomosis site and in the ileum after surgery, whether symptomatic or not, is high, at least 60% in one year and 80% within three years. The gold standard for monitoring being ileocolonoscopy, endoscopic surveillance is recommended in these patients, once between 6 to 12 months after surgery and then every 2 years.
The MRI enterography is a validated technique for the assessment of small bowel Crohn's disease. The enterography MRI is a validated technique for the assessment of small bowel Crohn's disease. The MRI enteroclysis was evaluated in two studies compared to endoscopy, with excellent performance in terms of recurrence detection sensitivity and suggested as an alternative to it to avoid an invasive procedure repeated in these patients. The MRI enterography (without enteroclysis) does not provide as good distension of the bowel loops as MRI enteroclysis because it relies on the principle of oral ingestion prior to the examination of large amounts of liquid. However, it is much better tolerated by the patient, does not involve radiation that exists with enteroclysis, is much simpler to use and requires no special equipment to magnetic fields.
Detailed Description
Determine the diagnostic performances of MRI enterography for the diagnosis of recurrence at the anastomosis site and in the ileum in patients with Crohn's disease who have had ileocolonic resection.
Assess the value of diffusion sequences of MRI enterography for the diagnosis of recurrence at the anastomosis site and in the ileum in patients with Crohn's disease who have had ileocolonic resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Patient's with Crohn's disease who have had ileocolic resection
Intervention Type
Other
Intervention Name(s)
MRI enterography
Primary Outcome Measure Information:
Title
recurrence at the anastomosis site and in the ileum
Description
Recurrence diagnosed with colonoscopy
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with Crohn's disease
patients with ileocolonic resection more than 6 months ago and less than 4 years ago
patients with indication of ileocolonoscopy
patient consenting to participate to the study
patient enrolled in the national healthcare insurance program
patient older than 18 years
Exclusion Criteria:
patients with contraindications for MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Truong Luong Francis NGUYEN
Email
tlnguyen@chu-reims.fr
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Truong Luong Francis NGUYEN
Email
tlnguyen@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study
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