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临床试验/NCT01183793
NCT01183793Unknown不适用

MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test

研究概览

简要总结

It is essential to know intestinal length and anastomotic type in post-operative short bowel syndrome patients. These parameters can help predict long-term intestinal failure with long-term parenteral nutrition usually needed for smallest lengths. Sometimes these parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is necessary to develop non-invasive and reproducible techniques to assess small bowel length. This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography and barium follow-through in this indication. There are at this time only two small studies evaluating barium follow-through for intestinal length measurement, and none evaluating MR-enterography. However, a major advantage of the latter is the lack of radiation exposure and possibility to perform 3D.

This will be an open labelled single center crossover study. Short bowel syndrome patients of the investigators center will be included after consent. The sequence of exams (MR enterography followed by barium follow-through or vice-versa) will be randomly assigned. Peroperative short bowel length measurement will be available for all patients. There will be one month between the two exams.

The main objective of this study is to assess the performance of MR-enterography in short bowel measurement in short bowel syndrome patients, the gold standard being peroperative length. Secondary objectives are to assess the performance of barium follow-through in short bowel measurement in these patients, and to show that barium follow-through does not perform better than MR-enterography. For that purpose the investigators will include 50 patients over 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intraoperative small bowel length < 200 cm
  • Males and females between 18 and 85 years of age
  • Patient with social insurance
  • Signature of informed consent

排除标准

  • Allergy to contrast product
  • Enterostomy closure expected within 2 months after randomization
  • Pregnancy or breast feeding woman
  • Swallowing disorders
  • Deprivation of liberty
  • Contraindications to magnetic resonance imaging (pace-maker, metal implant, known allergy to gadolinium)

结局指标

主要结局

Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test

时间窗: at 3 months

次要结局

  • Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test(at 3 months)

研究者

申办方类型
Other

研究点 (2)

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