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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01007786
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : June 14, 2012
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Utah

Brief Summary:
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.

Condition or disease
Pediatric Hydrocephalus

Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
Study Start Date : December 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007786

United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Canada, Ontario
Sick Children's Hospital
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair: William Whitehead, MD, MPH HCRN, Texas Children's Hospital
Principal Investigator: Jay Riva-Cambrin, MD HCRN, Primary Children's Medical Center
Principal Investigator: Abhaya Kulkarni, MD, PhD HCRN, Sick Children's Hospital, Toronto, Ontario
Principal Investigator: Jay Wellons, MD HCRN, Children's Hosptial of Alabama
Principal Investigator: John Kestle, MD Chair, Hydrocephalus Clinical Research Network

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Utah Identifier: NCT01007786     History of Changes
Other Study ID Numbers: 32371
HCRN 002 ( Other Identifier: HCRN Protocol Number )
1RC1NS068943-01 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by University of Utah:
Pediatric Hydrocephalus
Ultrasound Guided Surgery

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases