The CSF Shunt Entry Site Trial
Hydrocephalus
About this trial
This is an interventional treatment trial for Hydrocephalus focused on measuring Cerebrospinal Fluid Shunts, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- Less than 18 years of age at the time of shunt insertion; AND
- Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt as determined by a pediatric neurosurgeon; AND
- No prior history of shunt insertion (a history of an external ventricular drain, ventricular reservoir, subgaleal shunt, and or endoscopic third ventriculostomy with or without choroid plexus coagulation is permissible); AND
- Ventriculomegaly on imaging.
Exclusion Criteria:
- Need of a shunt that is not a simple ventriculoperitoneal shunt. For example: Patients who require more than one intracranial catheter are excluded. Patients who require a ventricular shunt that terminates in the atrium of the heart, the pleural cavity, the gallbladder, or any other terminal location that is not the peritoneal cavity are excluded. Patients who require a subdural to peritoneal or a cyst to peritoneal shunt are excluded.
- Active CSF or abdominal infection;
- CSF leak without hydrocephalus;
- Pseudotumor cerebri;
- Hydranencephaly;
- Loculations within the ventricular system (e.g. large intraventricular cysts or ventricular adhesions which create compartments that distort the ventricular anatomy; isolated trapped lateral ventricle). A small cyst within the ventricle does not meet these criteria;
- Other difficulties that would preclude follow up at one year (e.g. terminal illness with life expectancy less than 18 months; family plans to move out of region or country);
- A bilateral scalp, bone, or ventricular lesion that makes placement of either an anterior or a posterior shunt impracticable (e.g. cutis aplasia);
- Bilateral slit like frontal horns or trigones defined as the widest distance between the medial and lateral walls less than 3 millimeters.
- Patient is scheduled to have an intra-ventricular procedure (e.g. ETV, endoscopic biopsy, arachnoid cyst fenestration, fenestration of septum pellucidum) in addition to possible or definite VP shunt.
Sites / Locations
- Children's Hospital of Alabama
- Children's Hospital of Los Angeles
- Children's Hospital Colorado
- Johns Hopkins Children's Center
- St. Louis Children's Hospital
- Nationwide Children's Hospital
- Children's Hospital of Pittsburgh
- Monroe Carell Jr Children's Hospital at Vanderbilt
- Texas Children's Hospital
- Primary Children's Medical Center
- Seattle Children's Hospital
- Alberta Children's Hospital
- BC Children's Hospital
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Anterior Entry SIte
Posterior Entry Site
Anterior entry site is defined as shunt surgery with catheter entry into the brain from an opening near the coronal suture, on the top of the head and near the front. Specifically, anterior entry is defined as ventricular catheter entry less than 1 centimeter anterior to the coronal suture near the mid-pupillary line. Subjects randomized to this arm will undergo ventriculoperitoneal shunt insertion surgery using an anterior entry site.
Posterior entry site is defined as shunt surgery with catheter entry into the brain from an opening near the lambdoid suture, on the back of the head. Specifically, posterior entry is defined as ventricular catheter entry 4 to 7 centimeters above the external occipital protuberance (inion), near the mid-pupillary line. Subjects randomized to this arm will undergo ventriculoperitoneal shunt insertion surgery using a posterior entry site.