Overview

This trial is active, not recruiting.

Condition hydrocephalus
Treatments endoscopic third ventriculostomy, csf shunt insertion
Phase phase 2
Sponsor The Hospital for Sick Children
Collaborator The International Study Group for Neuroendoscopy (ISGNE)
Start date September 2005
End date December 2018
Trial size 182 participants
Trial identifier NCT00652470, 1000007601

Summary

The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
endoscopic third ventriculostomy
A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.
(Active Comparator)
csf shunt insertion
The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.

Primary Outcomes

Measure
Health Status Outcome as measured by the Health Utilities Index - 2
time frame: At 5 years of age

Secondary Outcomes

Measure
Death
time frame: Duration of the Study
Neurodevelopment as measured by the Denver Developmental Screening Test
time frame: Up to 3 years of Age
Health status outcome using the Hydrocephalus Outcome Questionnaire
time frame: At 5 years of Age
In-depth Evaluation of Neurodevelopment, Functioning and Intelligence, as mesured by the Weschler Intelligence Scale for Children or Weschler Preschool and Primary Scale of Intelligence
time frame: At 5 years of Age
Number of Subsequent Hydrocephalus-Related Operations
time frame: Duration of the Study
Surgical Morbidity
time frame: Duration of the Study
Incidence of failure of initial intervention
time frame: Duration of the Study
Hospitalization Time
time frame: 5 years post-operation
Need for repeat radiological scans
time frame: Duration of the Study
Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication
time frame: Duration of the Study
Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation
time frame: 3 years of age

Eligibility Criteria

Male or female participants up to 24 months old.

Inclusion Criteria: - Symptomatic TVH requiring treatment. - No previous treatment for TVH - Under 24 months of age at time of surgery - Full-term pregnancy (>36 weeks) - Mandatory pre-operative MRI that includes mid-sagittal T1 & T2 scans which show: Tri-ventricular pattern of hydrocephalus; proof of no flow through aqueduct; presence of CSF collection over the convexity and/or inter-hemispheric fissure is acceptable; configuration of third ventricle floor could vary; deformed tectal plate is acceptable; posterior fossa fluid collections may be included as long as: aqueduct is closed; vermis preserved (complete Dandy Walker Syndrome excluded); questionable flow in aqueduct acceptable as long as TVH exists - History or suggestion of intra-ventricular bleed (intra-uterine or post-natal) or intracranial infection qualifies (excluding intraventricular hemorrhage of prematurity). - Ability to participate in followup for at least 5 years Exclusion Criteria: - Open Spina Bifida - Complete Dandy Walker syndrome (vermian agenesis / dysgenesis) - Prematurity - Perinatal asphyxia - Severe dysmorphic anatomical features or known chromos (e.g. agenesis of corpus callosum, heterotopias, large cysts) - intracranial tumor

Additional Information

Official title International Infant Hydrocephalus Study: A Multicentre, Prospective Study
Principal investigator Abhaya Kulkarni, MD
Description TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection. TVH is currently treated through one of the following two approaches: - Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully. - Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.