Hydrocephalus in ChildrenVPS ETV MLNCT07330206
Precision Surgery for Pediatric Hydrocephalus: VPS vs. ETV With ML-Guided Prediction
An observational study of Hydrocephalus in Children, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Hydrocephalus in Children
- What is being tested?
- MRI-Guided Precision Shunt or ETV Strategy
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 20 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
- 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
- Being tested
- MRI-Guided Precision Shunt or ETV Strategy
- Keywords
- Ventriculoperitoneal Shunt, Endoscopic Third Ventriculostomy, Machine Learning, Individualized Treatment, Long-term Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-Guided Precision Shunt or ETV StrategyDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| ETV group | All undergo endoscopic third ventriculostomy as initial treatment Receives: 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) Receives: Diagnostic Test: MRI-Guided Precision Shunt or ETV Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate at 6 months post-operation
defined as stable or reduced ventricular volume on MRI/CT without need for re-intervention.
Measured: 6 months
Secondary outcomes (2)
2-year re-intervention rate
any re-operation or shunt revision after
Measured: 2 years
Cognitive improvement
≥10-point IQ gain or reaching age-appropriate level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2016
- Primary completion30 Dec 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus in ChildrenStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330206
- Sponsor's protocol ID
- WestChinaH-HX-2025-011
- Acronym
- VPS ETV ML
- Status last verified
- May 2024
- First submitted
- 29 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Treatment Strategies and Long-term Prognosis of Congenital Hydrocephalus: An Integrated Analysis Based on Multicenter Data and Machine Learning
- ClinicalTrials.gov ID
- NCT07330206
- Acronym / sponsor ID
- VPS ETV ML / WestChinaH-HX-2025-011
- Conditions
- Hydrocephalus in Children
- Keywords
- Ventriculoperitoneal Shunt, Endoscopic Third Ventriculostomy, Machine Learning, Individualized Treatment, Long-term Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETV group | – | Diagnostic Test: MRI-Guided Precision Shunt or ETV StrategyAll undergo endoscopic third ventriculostomy as initial treatment |
| VPS group | – | Diagnostic Test: MRI-Guided Precision Shunt or ETV Strategy* 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) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-Guided Precision Shunt or ETV Strategy | Diagnostic test | ETV group, VPS group |
Primary outcome
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.
2 secondary outcomes
2-year re-intervention rate
Time frame: 2 years
Cognitive improvement
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus in Children, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate at 6 months post-operation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.