Vanderbilt Clinical Trials

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Purpose

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.

Condition

Hydrocephalus

Eligibility

Eligible Ages: Under 104 Weeks
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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, 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

Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR 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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator ETV+CPC	Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus	Procedure: 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.
Active Comparator Ventriculoperitoneal Shunt	Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus	Device: 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.

Recruiting Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232

Contact:
Michelle Stone
205-639-7677
timoethia.m.stone@vumc.org

More Details

Status: Recruiting
Sponsor: University of Utah

Study Contact

Nichol Nunn
801-662-5344
nichol.nunn@hsc.utah.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.