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

NCT01007786 | Completed

• 3 other identifiers: 32371HCRN 0021RC1NS068943-01
• Study Type: observational
• Target: 67
• Locations: 2 countries
• Sites: 4

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.

Conditions

Pediatric Hydrocephalus

Keywords

Pediatric Hydrocephalus; Ultrasound Guided Surgery

Outcome Measures

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).

  The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion.

Secondary Outcomes (2)

• 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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.

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)

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (4)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Sick Children's Hospital

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 24116981 DERIVED

Related Links

• Hydrocephalus Clinical Research Network

Study Officials

• William Whitehead, MD, MPH

  HCRN, Texas Children's Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 4, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2011
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

US (3); CA (1)