HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
NCT ID: NCT04177914
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
176 participants
INTERVENTIONAL
2020-07-21
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ETV+CPC
Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus
Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.
Ventriculoperitoneal Shunt
Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus
Ventriculoperitoneal Shunt
The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.
Interventions
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Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.
Ventriculoperitoneal Shunt
The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.
Eligibility Criteria
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Inclusion Criteria
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, which 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
* 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 pressure with or without plateau waves
AND
4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
Exclusion Criteria
2. 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 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 an anterior shunt impracticable; OR
3. Underlying condition with a high chance of mortality within 12 months; OR
4. Hydrocephalus with loculated CSF compartments; OR
5. Peritoneal cavity not suitable for distal shunt placement; OR
6. Active CSF infection; OR
7. Hydranencephaly; OR
8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.
1 Day
104 Weeks
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
University of British Columbia
OTHER
University of Pittsburgh
OTHER
The Hospital for Sick Children
OTHER
Seattle Children's Hospital
OTHER
Vanderbilt University Medical Center
OTHER
Washington University School of Medicine
OTHER
Nationwide Children's Hospital
OTHER
Johns Hopkins University
OTHER
University of Calgary
OTHER
University of Colorado, Denver
OTHER
Children's Hospital Los Angeles
OTHER
National Institutes of Health (NIH)
NIH
Hydrocephalus Association
OTHER
Penn State University
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Baylor College of Medicine
OTHER
University of Florida
OTHER
Orlando Health, Inc.
OTHER
Virginia Commonwealth University
OTHER
Trustees of Indiana University
UNKNOWN
University of Utah
OTHER
Responsible Party
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John Kestle
MD, Vice Chair of Clinical Research
Principal Investigators
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John Kestle, MD
Role: STUDY_CHAIR
University of Utah
Abhaya Kulkarni, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
David Limbrick, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Richard Holubkov, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Wolfson Children's Hospital
Jacksonville, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Trustees of Indiana University
Indianapolis, Indiana, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
The Pennsylvania State University
University Park, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HCRN 012
Identifier Type: -
Identifier Source: org_study_id
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