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.

Study Overview

• Status: Completed
• Conditions: Pediatric Hydrocephalus

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Sick Children's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's Hospital of Alabama
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain).	The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion.

Secondary Outcome Measures

Outcome Measure	Time Frame
Shunt survival will be reported.	Up to one year after the date of shunt placement.
Any complications, intraoperative and postoperative, will be reported.	From the time of surgery until the time the subject is discharged from the hospital.

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: 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

Publications and helpful links

General Publications

• Whitehead WE, Riva-Cambrin J, Wellons JC 3rd, Kulkarni AV, Holubkov R, Illner A, Oakes WJ, Luerssen TG, Walker ML, Drake JM, Kestle JR; Hydrocephalus Clinical Research Network. No significant improvement in the rate of accurate ventricular catheter location using ultrasound-guided CSF shunt insertion: a prospective, controlled study by the Hydrocephalus Clinical Research Network. J Neurosurg Pediatr. 2013 Dec;12(6):565-74. doi: 10.3171/2013.9.PEDS1346. Epub 2013 Oct 11.

Helpful Links

• Hydrocephalus Clinical Research Network

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 2, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Pediatric Hydrocephalus; Ultrasound Guided Surgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: 32371; 1RC1NS068943-01 (U.S. NIH Grant/Contract); HCRN 002 (Other Identifier: HCRN Protocol Number)