跳至主要内容
临床试验/EUCTR2018-004852-39-FR
EUCTR2018-004852-39-FR进行中(未招募)1 期

Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial

CHU Dijon Bourgogne0 个研究点目标入组 1,200 人开始时间: 2019年3月14日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
1,200

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

  • - Age = 18 years
  • - Undergoing elective surgery for a digestive cancer (except purely hepatic surgery)
  • - Patients operated in a curative intent
  • - Patients who had given their written informed consent
  • - Patients affiliated to a National health insurance scheme
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Emergency surgery
  • - Pregnant or breastfeeding women
  • - Patients with an ongoing oral treatment by steroids
  • - Palliative surgery
  • - Exclusive liver surgery
  • - Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
  • - Patient with at least one contra-indication to methylprednisolone treatment :
  • * active infection
  • * on course viral disease (particularly hepatitis, herpes, chickenpox, herpes zoster
  • * uncontrolled psychotic state
  • * hypersensitivity to methylprednisolone or to one of its excipient
  • - ASA grade >3
  • - Persons subject to a measure of legal protection (guardianship, tutorship)
  • - Persons subject to a court order
  • - Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons

研究者

发起方
CHU Dijon Bourgogne

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