The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
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ClinicalTrials.gov Identifier: NCT01007786
Recruitment Status :
First Posted : November 4, 2009
Last Update Posted : June 14, 2012
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If reliable techniques for the accurate placement of ventricular catheters can be developed, shunt survival may improve. The purpose of this study is to assess the efficacy and safety of the ultrasound guided shunt insertion technique in the hands of experienced surgeons. The primary outcome measure is ventricular catheter location determined from post-operative brain images. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus. Pediatric neurosurgeons at HCRN centers enrolled in this study will perform either ultrasound guided shunt surgery or a conventional shunt surgery. Patients who undergo conventional shunt surgery will serve as a contemporary control group.
The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain). [ Time Frame: The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion. ]
Secondary Outcome Measures :
Shunt survival will be reported. [ Time Frame: Up to one year after the date of shunt placement. ]
Any complications, intraoperative and postoperative, will be reported. [ Time Frame: From the time of surgery until the time the subject is discharged from the hospital. ]
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Ages Eligible for Study:
up to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.
Patients must have clinical and radiographic evidence of hydrocephalus as determined by a pediatric neurosurgeon and require a ventriculoperitoneal shunt (atrial, pleural, gallbladder and other shunt systems are excluded)
Patients can have no prior history of shunt insertion for hydrocephalus. A history of an external ventricular drain, subgaleal reservoir-catheter, or subgaleal shunt is permissible
Patients must be less than 18 years of age at the time of shunt insertion
Active CSF or abdominal infection
Spread of tumor in the subarachnoid space documented on enhanced imaging (CT or MRI) of the head or spine
CSF leak without hydrocephalus
Dandy-Walker malformation or arachnoid cyst as a cause of hydrocephalus
Loculations within the ventricular system
Hydranencephaly, alobar holoprosencephaly or any other congenital anomaly of the brain that severely distorts the ventricular anatomy such that ventricular catheter location cannot be determined
Other systemic disorders that would preclude the insertion/revision of a ventricular shunt
Other difficulties that would preclude follow-up at one year (e.g. terminal illness with life expectancy less than 1 year)