跳至主要内容
临床试验/NCT06708689
NCT06708689进行中(未招募)不适用

Retrospective Case-control Study of Central Line Botriomycoma in Children on Home Parenteral Nutrition: Epidemiology, Risk Factors, Treatments

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240
试验地点
1
主要终点
Appearance of Botryomycoma

研究概览

简要总结

Botriomycomas are frequent benign tumors in children. Their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. This lesion could lead to changes in pathways and an increase in the number of sepsis events, which would promote thrombosis and thus depletion of venous capital in patients who have been dependent on a central line for many years.

This study is a pilot study which will enable us to better identify the risk factors for the development of such a tumour, and to take stock of the different treatments used and their respective efficacy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • home parenteral nutrition patients
  • never diagnosed with an episode of botriomycoma on their central line
  • 0 to 18 years of age at diagnosis

排除标准

  • Botriomycoma more than 10 years old at time of data collection (or lack of data)
  • Patient over 18 years of age
  • Not on home parenteral nutrition patients

结局指标

主要结局

Appearance of Botryomycoma

时间窗: From first diagnosis through a follow-up period of 2 years.

genetic characteristics (origin, phototype), local factors (mechanical, infectious), and general factors (history of sepsis).

Recurrence of Botryomycoma

时间窗: From first diagnosis through a follow-up period of 2 years.

analyze risk factors for recurrence and evolution under different treatments.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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