跳至主要内容
临床试验/NCT02872623
NCT02872623Unknown不适用

EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study

CHU de Reims2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
40
试验地点
2
主要终点
Presence of a tumor of the small intestine

研究概览

简要总结

Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.

详细描述

Evaluate the diagnostic performances of enteroCT with enteroclysis and enterography-MRI without enteroclysis, for the diagnosis of tumor of the small intestine, among patients with suspicion of small intestine tumors.

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

入选标准

  • patient clinically suspected of having a tumor of the small intestine
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

排除标准

  • patient with inflammatory bowel disease
  • patient with contraindication for MRI

结局指标

主要结局

Presence of a tumor of the small intestine

时间窗: 12 months

Presence of a tumor of the small intestine diagnosed using pathological results or using clinical evaluation at 12 months (if no biopsy is performed).

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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