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

2019年6月18日 更新者:Rennes University Hospital

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

Observational study

研究概览

地位

完全的

条件

详细说明

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).

A recent study under submission has developed an ultrasound score of Crohn's disease activity, which through the study of each segment (distal ileum, right colon / transverse / left, sigmoid) using 14 criteria , allowed to rule on the activity of the disease and thus to predict mucosal healing. In this study, which concerned 48 patients, ultrasound scans were performed by radiologists experienced in abdominal pathology. This score was very easy to use and powerful to study the disease activity of each segment with 2 parameters in particular: parietal thickness and changes in fat.

It therefore seems necessary to confirm the simplicity of this ultrasound score in a validation cohort to: in particular to study the inter-observer reproducibility so as to be able to extend the use of this score to non-specialist radiologists.

研究类型

观察性的

注册 (实际的)

51

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Rennes、法国、35033
        • Rennes University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients followed for Crohn's disease

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:仅案例
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity
大体时间: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
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Guillaume Bouguen、Rennes University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年2月13日

初级完成 (实际的)

2019年4月1日

研究完成 (实际的)

2019年4月1日

研究注册日期

首次提交

2018年2月13日

首先提交符合 QC 标准的

2018年2月13日

首次发布 (实际的)

2018年2月20日

研究记录更新

最后更新发布 (实际的)

2019年6月19日

上次提交的符合 QC 标准的更新

2019年6月18日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 35RC18_3094_ECHOCROHN

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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