HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2026
  • participants needed
    176
  • sponsor
    University of Utah
Updated on 11 August 2022
endoscopic procedure
tense
ventriculoperitoneal shunt
hydrocephalus in infants
endoscopic third ventriculostomy
hcrn

Summary

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.

Description

The ESTHI Trial is a multi-center randomized controlled trial (RCT) comparing endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC) and shunt in infants with hydrocephalus. The study will leverage the infrastructure of the Hydrocephalus Clinical Research Network (HCRN), a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome is the primary concern of families and will, therefore, be the primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these two treatments. The results of the RCT will help families determine the optimal treatment of hydrocephalus for their child.

Details
Condition Hydrocephalus
Treatment Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), Ventriculoperitoneal Shunt, Ventriculoperitoneal Shunt
Clinical Study IdentifierNCT04177914
SponsorUniversity of Utah
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Corrected age <104 weeks and 0 days
AND
Child is ≥ 37 weeks post menstrual age
Child must have symptomatic hydrocephalus, defined as
Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, which
AND
approximates "moderate ventriculomegaly"), and at least one of the following
Head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures
Upgaze paresis/palsy (sundowning)
CSF leak
Tense pseudomeningocele or tense fluid along a track
Papilledema
Vomiting or irritability, with no other attributable cause
Bradycardias or apneas, with no other attributable cause
Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves
No prior history of shunt insertion or endoscopic third ventriculostomy (ETV)
AND
procedure (previous temporization devices and/or external ventricular drains
permissible)

Exclusion Criteria

Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks
gestational age; OR
Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt
defined as
Moderate to severe prepontine adhesions on steady state free precession (SSFP) or
T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following
Closure of one or both foramina of Monro
sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE
VISTA, IsoFSE, and 3D MVOX
Narrow third ventricle (<5mm)
Thick floor of third ventricle (≥ 3mm)
Underlying condition with a high chance of mortality within 12 months; OR
Hydrocephalus with loculated CSF compartments; OR
Peritoneal cavity not suitable for distal shunt placement; OR
Presence of scalp, bone, or ventricular lesions that make placement of an
Active CSF infection; OR
anterior shunt impracticable; OR
Hydranencephaly; OR
Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to
the initial first-time permanent procedure for the treatment of hydrocephalus
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