NCT07330206

Precision Surgery for Pediatric Hydrocephalus: VPS vs. ETV With ML-Guided Prediction

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hydrocephalus in Children

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI-Guided Precision Shunt or ETV Strategy

Timeline

• Start date: 2016-01-01
• Primary completion: 2023-12-30
• Completion: 2024-01-20
• First posted: 2026-01-09
• Last updated: 2026-01-12

Locations

1 site across 1 country: China