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OpenTrials
Completed

NCT Number: NCT01007786

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

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.

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Key information

Conditions

Pediatric Hydrocephalus

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sick Children's Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Shunt survival will be reported.

    Time frame: Up to one year after the date of shunt placement.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Nov 4, 2009
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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