Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study

NCT02867540 | Unknown

• 1 other identifier: PA14058
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• recurrence at the anastomosis site and in the ileum

  Recurrence diagnosed with colonoscopy

  Day 1

Study Arms (1)

experimental group

EXPERIMENTAL

Patient's with Crohn's disease who have had ileocolic resection

Other: MRI enterography

Interventions

MRI enterography OTHER

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with contraindications for MRI

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Truong Luong Francis NGUYEN

CONTACT

tlnguyen@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

FR (1)