Individualized Treatment Strategies and Long-term Prognosis of Congenital Hydrocephalus: An Integrated Analysis Based on Multicenter Data and Machine Learning
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
- 否
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
Zhigang Lan
Professor
West China Hospital
