The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique

Completed

Conditions studied: Pediatric Hydrocephalus

In brief

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.

Key facts

Study ID

NCT01007786

Run by

University of Utah

People needed

67

Starts

2008-12-01

Expected to finish

2011-03-01

Last updated by the study team

2012-06-14

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Pseudotumor cerebri
• 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)

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Sick Children's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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