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

Completed

• Conditions: Pediatric Hydrocephalus

• Registration Number: NCT01007786
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-04
• Primary Completion: 2010-02
• Study Completion: 2011-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (4)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Sick Children's Hospital; 🇨🇦 Toronto, Ontario, Canada

Primary Children's Medical Center; 🇺🇸 Salt Lake City, Utah, United States