Clinical trial NCT04324632: Magnetic Resonance Enterography in Inflammatory Bowel Diseases
Official title: Role of Magnetic Resonance Enterography (MRE) in Assessment of Inflammatory Bowel Diseases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: MRE
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects of both sexes with different age groups diagnosed to have inflammatory bowel disease

Brief summary: Assess the accuracy of magnetic resonance-enterography in predicting the extension, location and characteristics of the small bowel segments affected by Crohn's disease\& determine the diagnostic performance of standard MR enterography in detecting colonic inflammation and investigate MR enterography's ability to grade inflammatory activity and detect intestinal extra intestinal manifestations

Detailed description: Inflammatory bowel diseases (IBD) are chronic disorders of the gastrointestinal tract with a remitting-relapsing disease pattern. Ulcerative colitis (UC) and Crohn's disease (CD) represent the two main forms of IBD.

In CD inflammation affects various parts of the bowel, separated by unchanged intestinal segments, while in ulcerative colitis enteric involvement is continuous, extending from the rectum throughout the colon. Additionally, in Crohn's disease the inflammatory process spreads through all layers of the intestinal wall, while in UC only the mucosa and sub mucosa are affected.

Imaging findings, endoscopic studies and histological data together with clinical assessment, can be used to help distinguish these two forms, determine prognosis, assess disease activity and to inform treatment decision-making.

A "treat-to-target" strategy with close monitoring of intestinal inflammation is recommended in inflammatory bowel disease (IBD). Ileocolonoscopy (CS) remains the gold-standard for assessing disease activity in IBD but is a relatively invasive procedure and is impossible to repeat in the context of tight monitoring strategies.

MRE is preferred over computed tomography enterography by most radiologists and gastroenterologists because of the potential for differentiating active inflammation from fibrotic strictures, and due to the lack of exposure to ionizing radiation. This is especially true in children, as the onset of IBD in childhood is a known risk factor for high cumulative exposure to ionizing radiation from imaging.

MRE furthermore provides a transmural study of bowel loops (oedema, wall thickening, and enhancement post contrast). These features make MRE ideally suitable to the IBD population.

Eligibility criteria: Inclusion Criteria:

* Patients with different age groups and both sex are eligible for our prospective study

  1. Either they had undergone colonoscopy or colonoscopy was planned, and they have been recently diagnosed with IBD.
  2. Suspected to have disease relapse.

Exclusion Criteria:

Participants are not eligible for our prospective study if they:

1. Have evidence of severe or uncontrolled systemic disease that rendered the individual unsuitable for participation.
2. Have contraindications to MRE (e.g. allergy to all suitable contrast agents, cardiac pacemaker, severe claustrophobia, an inability to lie flat).
3. Had a final diagnosis other than IBD.

Primary outcomes:
measure: comparison of magnetic resonance enterography findings with colonoscopic findings and clinical activity scores of IBD
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: