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临床试验/NCT07330206
NCT07330206已完成不适用

Individualized Treatment Strategies and Long-term Prognosis of Congenital Hydrocephalus: An Integrated Analysis Based on Multicenter Data and Machine Learning

West China Hospital1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2016年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
800
试验地点
1
主要终点
Surgical success rate at 6 months post-operation

研究概览

简要总结

Study type: Multicenter retrospective cohort study with prospective validation Primary purpose: To determine whether an individualized, imaging-guided treatment algorithm Ventriculoperitoneal shunt (VPS) vs endoscopic third ventriculostomy (ETV) improves 2-year neurodevelopmental outcomes in children <18 y with congenital hydrocephalus.

Main questions

  • Does ETV produce higher 6-month surgical success and lower 2-year re-intervention rates than VPS in prespecified subgroups (age ≥3 y, obstructive hydrocephalus, normal basal cisterns)?
  • Does a machine-learning model (ETV-PS) using pre-operative MRI features accurately predict ETV success (AUC ≥0.80) and thereby reduce unnecessary re-operations?
  • Does early, frequent programmable-valve pressure adjustment after VPS decrease over-shunting headaches and improve 2-year cognitive scores compared with standard, infrequent adjustment?

Comparison: ETV group vs. VPS group (1:1 propensity-matched); within VPS cohort, frequent (≥3 adjustments in first 6 mo) vs. infrequent (<3) pressure-tuning arms.

Participants will

  • Provide pre-operative clinical data and MRI/CT imaging.
  • Undergo either VPS or ETV as clinically indicated; 320 VPS recipients receive programmable valves with protocol-driven pressure logs.
  • Return for standardized neurodevelopmental testing Children's Memory Scale (CMS), Wechsler Intelligence Scale for Children(WISC), Pediatric Quality of Life Inventory(PedsQL) and imaging at 6 mo, 1 y and 2 y; valve adjustments tracked electronically.

研究设计

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

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 0-17.99 years at surgery
  • Congenital hydrocephalus confirmed by clinical and MRI/CT findings
  • First surgical treatment: either VPS or ETV
  • Complete pre-operative MRI/CT and ≥ 2-year follow-up data available

排除标准

  • Secondary hydrocephalus (tumor, infection, trauma)
  • Severe comorbidities affecting neuro-developmental assessment (e.g., major congenital heart disease, genetic-metabolic disorders)
  • Incomplete baseline imaging or follow-up < 2 years

研究组 & 干预措施

ETV group

All undergo endoscopic third ventriculostomy as initial treatment

干预措施: MRI-Guided Precision Shunt or ETV Strategy (Diagnostic Test)

VPS group

  • 320 receive a programmable valve with protocol-driven pressure adjustments
  • 80 receive a fixed-pressure valve (included only in VPS-vs-ETV comparisons, excluded from valve-management sub-analysis)

干预措施: MRI-Guided Precision Shunt or ETV Strategy (Diagnostic Test)

结局指标

主要结局

Surgical success rate at 6 months post-operation

时间窗: 6 months

defined as stable or reduced ventricular volume on MRI/CT without need for re-intervention.

次要结局

  • 2-year re-intervention rate(2 years)
  • Cognitive improvement(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhigang Lan

Professor

West China Hospital

研究点 (1)

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