跳至主要内容
临床试验/NCT03439826
NCT03439826已完成不适用

Junior / Senior Concordance in Ultrasound Assessment of Crohn's Disease (ECHOCROHN)

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity

研究概览

简要总结

Observational study

详细描述

Crohn's disease is a chronic inflammatory disease of the intestine (IBD), evolving with varying periods of remissions and relapses, characterized by segmental inflammation of the digestive tract, which can be complicated by stenosis, fistulas or even digestive cancers.

The emergence of effective therapeutic strategies has led to the adoption of more ambitious therapeutic objectives that have no longer the improvement of symptoms but a complete cicatrization of the intestinal mucosa as an objective.

The disadvantage of the latter is the need for its evaluation by ilo-colonoscopy, "gold-standard", invasive, not without risks (perforation, anesthesia, hemorrhage), requiring colonic preparation and hospitalization.

In this context, the use of non-invasive markers performed in routine practice (hemogram, VS, CRP, fibrinogen, fecal calprotectin, abdominal ultrasound), predictive of this endoscopic mucosal healing, is a necessity to improve the tolerance of follow-up and allow better adherence by the patient of the therapeutic project. A decrease in health costs could also be associated with the use of these markers.

Abdominal ultrasound is an accessible, inexpensive, non-invasive and non-irradiating imaging medium. It is very useful and has proved its effectiveness in monitoring Crohn's disease to evaluate the activity of the disease in order to predict mucosal healing and to detect complications (stenosis, fistula, abscess) (1, 2, 3). However, especially for the study of the small intestine this act is known to be very dependent on the operator and the conditions of examination (echogenicity of the patient). In addition, few objective criteria have been described in the literature for the study of Crohn's disease (2, 3).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients followed for Crohn's disease;
  • Crohn's disease diagnosed in accordance with the criteria of the European Crohn's and Colitis Organization (ECCO);
  • Benefiting from an abdominal ultrasound as part of their usual follow-up;
  • Not having expressed his opposition to participate in the study.

排除标准

  • Persons of legal age subject to legal protection (protection of justice, guardianship, tutorship), persons deprived of their liberty.

结局指标

主要结局

Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity

时间窗: Baseline

These criteria are to be found on each segment: terminal ileum, right colon, transverse colon, left colon and sigmoid. * Normal appearance: yes / no * Maximum parietal wall thickness (mm) * parietal differentiation: yes / no * Ulceration: yes / no * Fistula: yes / no * Infiltration of peripheral fat: yes / no * Sclerolipomatosis: yes / no * Stenosis: yes / no Criterion for the entire abdominal cavity : * Mesangular ganglion\> 5mm: yes / no * Intraperitoneal fluid effusion: yes / no Abdominal abscess: yes / no * dilated handles: yes / no * Total length of reach (in mm) * Distance to the valve

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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