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临床试验/NCT04324632
NCT04324632Unknown不适用

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

Assiut University0 个研究点目标入组 30 人开始时间: 2020年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
comparison of magnetic resonance enterography findings with colonoscopic findings and clinical activity scores of IBD

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with different age groups and both sex are eligible for our prospective study
  • Either they had undergone colonoscopy or colonoscopy was planned, and they have been recently diagnosed with IBD.
  • Suspected to have disease relapse.

排除标准

  • Participants are not eligible for our prospective study if they:
  • Have evidence of severe or uncontrolled systemic disease that rendered the individual unsuitable for participation.
  • Have contraindications to MRE (e.g. allergy to all suitable contrast agents, cardiac pacemaker, severe claustrophobia, an inability to lie flat).
  • Had a final diagnosis other than IBD.

结局指标

主要结局

comparison of magnetic resonance enterography findings with colonoscopic findings and clinical activity scores of IBD

时间窗: two years

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hayam Yahia Hmed Khalil

principal invistigator

Assiut University

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