Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study (MRI-CROHN)
|ClinicalTrials.gov Identifier: NCT02867540|
Recruitment Status : Unknown
Verified August 2016 by CHU de Reims.
Recruitment status was: Recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Other: MRI enterography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||May 2017|
Experimental: experimental group
Patient's with Crohn's disease who have had ileocolic resection
Other: MRI enterography
- recurrence at the anastomosis site and in the ileum [ Time Frame: Day 1 ]Recurrence diagnosed with colonoscopy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867540
|Contact: Truong Luong Francis NGUYENfirstname.lastname@example.org|
|Chu de Reims||Recruiting|
|Reims, France, 51092|
|Contact: Truong Luong Francis NGUYEN email@example.com|