Clinical trial NCT01007786: The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
Official title: The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Hydrocephalus
Keywords: Pediatric Hydrocephalus
Ultrasound Guided Surgery
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-11-04
Enrollment: 67
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain).
timeFrame: The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion.
Secondary outcomes:
measure: Shunt survival will be reported.
timeFrame: Up to one year after the date of shunt placement.
measure: Any complications, intraoperative and postoperative, will be reported.
timeFrame: From the time of surgery until the time the subject is discharged from the hospital.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Toronto
country: Canada
facility: Sick Children's Hospital
state: Ontario
Study officials:
affiliation: HCRN, Texas Children's Hospital
name: William Whitehead, MD, MPH
role: STUDY_CHAIR
affiliation: HCRN, Primary Children's Medical Center
name: Jay Riva-Cambrin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCRN, Sick Children's Hospital, Toronto, Ontario
name: Abhaya Kulkarni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCRN, Children's Hosptial of Alabama
name: Jay Wellons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair, Hydrocephalus Clinical Research Network
name: John Kestle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.