Magnetic Resonance Enterography in Inflammatory Bowel Diseases

Inflammatory Bowel Diseases Clinical Trial

Official title:

Role of Magnetic Resonance Enterography (MRE) in Assessment of Inflammatory Bowel Diseases.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04324632
• Other study ID #: MRE in IBD
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: April 2022

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Hayam Yahia Hamed Khalil, assisstant lecturer
• Phone: 01067949776
• Email: hayamyahia1989[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of magnetic resonance enterography findings with colonoscopic findings and clinical activity scores of IBD	To investigate MR enterography's ability to detect to the extension, location and characteristics of intestinal segments affected by IBD and grade inflammatory activity in correlation with endoscopic findings.	two years