Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Technical characteristics of the examination MRIs represented by the sensibility and the specificity of the test, with regard to the results stemming from the surgical operation
研究概览
简要总结
Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a large serie of surgically verified cases.
详细描述
Classical imaging techniques are inaccurate to detect residual cholesteatoma. Thin-section CT detects that the postoperative cavity is filled with a soft tissue mass. Classical MR imaging (T2 and T1 weighted spin-echo sequences) can not provide additionnal information about the nature of this filling : cholesteatoma, granulation or fibrous tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male child enters 5 and 18 years
- •Child having benefited from a surgical operation for cholesteatoma of the average ear acquired or congenital, one-sided or bilateral
- •Child for whom an additional operating time is indicated
- •Child without contraindication in the MRI
- •Child having signed a enlightened assent
- •Child among whom the parents or the legal representatives signed a enlightened assent
排除标准
- •Child of less than 5 years old and more than 18 years
- •Child presenting a chronic renal insufficiency
- •Child for whom an additional operating time is not indicated
- •Child having a contraindication in the MRI
- •Child not having signed the assent or the parents of which did not sign the assent
研究组 & 干预措施
1
Analysis of the value of the imaging of distribution and the late sequence to differentiate the cholesteatoma of the fibrosis in the follow-up operating post at the child
干预措施: MR Imaging (Other)
结局指标
主要结局
Technical characteristics of the examination MRIs represented by the sensibility and the specificity of the test, with regard to the results stemming from the surgical operation
时间窗: 24 months
次要结局
- Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.(24 months)
- It is necessary to test the following diagnostic method: the analysis of the morphological sequences in T1 and in T2 will allow to appreciate the existence or not of a filling of the cavity tympanique or the mastoïde and to clarify its localization.(24 months)