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临床试验/EUCTR2013-003998-10-NL
EUCTR2013-003998-10-NL进行中(未招募)1 期

A randomized clinical trial investigating Lanreotide For output reduction in patients with high-output Enterocutaneous fistula - LIFE study

Academic medical center0 个研究点开始时间: 2013年10月18日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Adult patients with high output enterocutaneous fistula (>500ml/day) or high output enterostomy (>1500ml/day) existing for at 4 weeks after surgery where the clinical decision has been made by the treating team to reduce output using medical therapy (standard regimen, i.e. PPI, codeine, loperamide, reduction in oral intake) for at least 2 weeks.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Recent treatment with short-acting somatostatin (or analogues) for a consecutive period of more than 1 week (within past 3 months)
  • Patients with high output pancreatic fistula after pancreatitis
  • Patients with symptomatic gallbladder disease

研究者

发起方
Academic medical center

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