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

Pediatric Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007786
• Other study ID #: 32371
• Secondary ID: HCRN 0021RC1NS06
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: June 12, 2012
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Research Ethics Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hydrocephalus
• Pediatric Hydrocephalus

Locations

Country	Name	City	State
Canada	Sick Children's Hospital	Toronto	Ontario
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Texas Children's Hospital	Houston	Texas
United States	Primary Children's Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Shunt survival will be reported.		Up to one year after the date of shunt placement.	No
Secondary	Any complications, intraoperative and postoperative, will be reported.		From the time of surgery until the time the subject is discharged from the hospital.	No

External Links

•   Hydrocephalus Clinical Research Network