Trials / Unknown
UnknownNCT02425761
The CSF Shunt Entry Site Trial
A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 448 (actual)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- All
- Age
- 1 Day – 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Ventriculoperitoneal shunt insertion surgery | 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. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2015-04-24
- Last updated
- 2020-11-12
Locations
14 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02425761. Inclusion in this directory is not an endorsement.