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OpenTrials
Completed

NCT Number: NCT07330206

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI-Guided Precision Shunt or ETV Strategy

Diagnostic Test

Primary outcomes

  1. Surgical success rate at 6 months post-operation

    Time frame: 6 months

    defined as stable or reduced ventricular volume on MRI/CT without need for re-intervention.

Secondary outcomes

  1. 2-year re-intervention rate

    Time frame: 2 years

    any re-operation or shunt revision after

  2. Cognitive improvement

    Time frame: 2 years

    ≥10-point IQ gain or reaching age-appropriate level

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Acronym: VPS ETV ML

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Jan 9, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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