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

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

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.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus in Children
• Intervention / Treatment: Diagnostic test: MRI-Guided Precision Shunt or ETV Strategy

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

800 children ≤17 years with congenital hydrocephalus recruited from 6 tertiary pediatric neurosurgical centers; 1:1 matched VPS (n=400) vs ETV (n=400) cohorts balanced for age, sex, and hydrocephalus subtype.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ETV group; All undergo endoscopic third ventriculostomy as initial treatment	Diagnostic test: MRI-Guided Precision Shunt or ETV Strategy
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)	Diagnostic test: MRI-Guided Precision Shunt or ETV Strategy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Estimated): January 9, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Machine Learning; Ventriculoperitoneal Shunt; Individualized Treatment; Long-term Prognosis; Endoscopic Third Ventriculostomy
• Other Study ID Numbers: WestChinaH-HX-2025-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No