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临床试验/NCT00789841
NCT00789841已完成不适用

Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR

University of Aarhus1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Gastrointestinal transit time in NET patients

研究概览

简要总结

We will study the total gastrointestinal transit time (GITT), gastric emptying and small intestine motility in NET patients before and after treated with somatostatin analogues and compare these to healthy subjects. For this we will use radio-opaque markers and the newly developed Motility Tracking System (MTS).

Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying and small bowel transit time and an increase in phase III MMC activity compared to healthy subjects. Treatment with somatostatin analogues increase transit times and decrease phase III MMC activity and improves the clinical symptoms.

研究设计

研究类型
Observational

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • NET confirmed by histology
  • Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.
  • Newly referred patients without previous somatostatin analogue treatment or
  • NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.

排除标准

  • Subjects unable to understand the information
  • Severe diabetes with late complications or known metabolic disorder
  • Inflammatory bowel disease
  • Known clinically significant stenosis of the bowel
  • Bile acid malabsorption due to intestinal surgery
  • Small bowl bacterial overgrowth

结局指标

主要结局

Gastrointestinal transit time in NET patients

时间窗: End of the study

次要结局

  • Gastric emptying in NET patients(End of the study)
  • Small intestinal transit time(End of the study)
  • Small intestinal velocity(End of the study)
  • Changes in carcinoid symptoms and biomarkers(End of the study)

研究者

申办方类型
Other

研究点 (1)

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