HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Last updated: June 20, 2024
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Ventriculoperitoneal Shunt

Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)

Clinical Study ID

NCT04177914
HCRN 012
1U01NS107486-01A1
  • Ages 1-104
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Corrected age <104 weeks and 0 days, AND

  2. Child is ≥ 37 weeks post menstrual age, AND

  3. Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, whichapproximates "moderate ventriculomegaly"), and at least one of the following:

  • Head circumference >98th percentile for corrected age with either bulgingfontanelle or splayed sutures

  • Upgaze paresis/palsy (sundowning)

  • CSF leak

  • Papilledema

  • Tense pseudomeningocele or tense fluid along a track

  • Vomiting or irritability, with no other attributable cause

  • Bradycardias or apneas, with no other attributable cause

  • Intracranial pressure (ICP) monitoring showing persistent elevation of pressurewith or without plateau waves AND

  1. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV)procedure (previous temporization devices and/or external ventricular drainspermissible)

Exclusion

Exclusion Criteria:

  1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeksgestational age; OR

  2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shuntdefined as:

  • Moderate to severe prepontine adhesions on steady state free precession (SSFP)or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes thefollowing sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE),CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX

  • Closure of one or both foramina of Monro

  • Thick floor of third ventricle (≥ 3mm)

  • Narrow third ventricle (<5mm)

  • Presence of scalp, bone, or ventricular lesions that make placement of ananterior shunt impracticable; OR

  1. Underlying condition with a high chance of mortality within 12 months; OR

  2. Hydrocephalus with loculated CSF compartments; OR

  3. Peritoneal cavity not suitable for distal shunt placement; OR

  4. Active CSF infection; OR

  5. Hydranencephaly; OR

  6. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition tothe initial first-time permanent procedure for the treatment of hydrocephalus.

Study Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: Ventriculoperitoneal Shunt
Phase: 3
Study Start date:
July 21, 2020
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Active - Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Children's of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Children's Hospital of Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Wolfson Children's Hospital

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Johns Hopkins Children's Center

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Active - Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • The Pennsylvania State University

    University Park, Pennsylvania 16802
    United States

    Site Not Available

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah 84118
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

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