The CSF Shunt Entry Site Trial

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.

Inclusion Criteria:

1. Less than 18 years of age at the time of shunt insertion; AND

2. Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt
as determined by a pediatric neurosurgeon; AND

3. 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

4. Ventriculomegaly on imaging.

Exclusion Criteria:

1. 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.

2. Active CSF or abdominal infection;

3. CSF leak without hydrocephalus;

4. Pseudotumor cerebri;

5. Hydranencephaly;

6. 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;

7. 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);

8. A bilateral scalp, bone, or ventricular lesion that makes placement of either an
anterior or a posterior shunt impracticable (e.g. cutis aplasia);

9. Bilateral slit like frontal horns or trigones defined as the widest distance between
the medial and lateral walls less than 3 millimeters.

10. 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.