The purpose of the study is to compare the survival time (time to first shunt failure) of ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted through a posterior entry site in children. Shunt entry site is the location on the head that the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the ventricles. Entry sites can be anterior or posterior.
The study is a multi-centered, randomized, controlled trial comparing two commonly used CSF shunt insertion techniques, anterior and posterior entry site. There is conflicting information and opinions in the pediatric hydrocephalus literature regarding entry site's effect on shunt survival. This trial is designed to detect a 10% or more difference in the rate of shunt survival at one year between the two techniques. The trial will be conducted by the Hydrocephalus Clinical Research Network and the Hydrocephalus Association. It is a four year study with an estimated sample size of 448 patients. Patients will be randomized in the operating room. Subjects will be followed for a minimum of 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
448
The most common treatment for hydrocephalus is the placement of a ventriculoperitoneal shunt in the operating room. A shunt is a flexible tube placed into the ventricular system, fluid filled chambers, of the brain that diverts the flow of CSF into another region of the body, usually the abdomen, also known as the peritoneal cavity, where it can be absorbed.
Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Shunt Failure determined by clinical and radiographic findings
Shunt failure occurs when the shunt is obstructed, infected, over-drains, or does not drain the entire ventricular system. Shunt failure will be confirmed by radiographic and/ or operative findings, and all failures will be reviewed by a blinded adjudication committee. Subjects will be monitored for shunt failure at each scheduled and unscheduled clinical visit throughout the study. Survival analysis will be used to compare time to shunt failure in each treatment group. The last subject entered into the trial will be followed for 18 months and accrual is expected to take 26 months (maximum follow up 44 months).
Time frame: Within 18 months to 44 months from shunt insertion surgery
Patient quality of life measured by the Pediatric Quality of Life Inventory (PedsQL)
A validated quality of life measure will be administered to all subjects/ caretakers at enrollment and at the above time intervals.
Time frame: 1 week and 1 year after shunt surgery
Duration of surgery (minutes)
Time frame: Shunt insertion surgery
Location of ventricular catheter tip on brain imaging
Position of the ventricular catheter on the first postoperative imaging study will be assessed on postoperative imaging studies obtained within 1 year of shunt insertion surgery. The frequency of catheter tips in poor locations (e.g. within brain parenchyma) will be compared between treatment groups.
Time frame: within 1 year of shunt surgery
Number and type of shunt revisions
The number of shunt revisions required by each subject from the time of shunt insertion to the conclusion of the study will be compared. All subjects will be followed for at least 18 months.
Time frame: Within 18 months to 44 months from shunt insertion surgery
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Denver, Colorado, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
...and 4 more locations