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

NCT07330206 | Completed DMC

• 1 other identifier: WestChinaH-HX-2025-011
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus in Children

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 2-year re-intervention rate

  2 years

• Cognitive improvement

  2 years

Study Arms (2)

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

Interventions

MRI-Guided Precision Shunt or ETV Strategy DIAGNOSTIC_TEST

ETV group; VPS group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2016
• Primary Completion: December 30, 2023
• Study Completion: January 20, 2024
• Last Updated: January 12, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)