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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07330206

Acronym

VPS ETV ML

Enrollment

800

Registered

2026-01-09

Start date

2016-01-01

Completion date

2024-01-20

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus in Children

Keywords

Ventriculoperitoneal Shunt, Endoscopic Third Ventriculostomy, Machine Learning, Individualized Treatment, Long-term Prognosis

Brief 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.

Interventions

DIAGNOSTIC_TESTMRI-Guided Precision Shunt or ETV Strategy

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Surgical success rate at 6 months post-operation	6 months	defined as stable or reduced ventricular volume on MRI/CT without need for re-intervention.

Secondary

Measure	Time frame	Description
2-year re-intervention rate	2 years	any re-operation or shunt revision after
Cognitive improvement	2 years	≥10-point IQ gain or reaching age-appropriate level

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026