Communicating Hydrocephalus Clinical Trial
Official title:
A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus
Ventriculoperitoneal shunts are the standard of care for patients with communicating
hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail
within 2 years. It has long been assumed that endoscopic third ventriculostomy (ETV) would
not work in this population and is better suited to patients with obstructive hydrocephalus
(such as from a tumor blocking cerebral-spinal fluid (CSF) pathways). However, as scientists
learn more about CSF and the way our brains absorb this fluid, they have learned that this
may not be so straight-forward. Recent small studies have shown that ETVs can work in a good
percentage of children with communicating hydrocephalus, too. But no randomized controlled
trials have been done to compare these two treatments directly to determine which will
provide children with a better prognosis, fewer surgeries over their lifetime, less time in
the hospital and the greatest chance at as normal a life as possible.
The investigators will conduct a trial to compare these two surgical treatments where
patients will be randomized to receive either a shunt or an ETV. Because ETV has been shown
to have a high failure rate in newborns, the investigators will not include these patients
and instead will study patients who come to Duke University with communicating hydrocephalus
between the ages of 1 year and 18 years. The study will include patients with ventricular
shunts who are in need of revision and patients who were just diagnosed and need their first
shunt.
All patients who agree to participate will be randomized to receive either an ETV or a
shunt. The study team will follow them for one year from the time of the surgery and will
determine what percentage of patients require further CSF-related surgeries, how long they
go after their surgery before they need another surgery, how much time they spend in the
hospital and what percentage of patients suffer CSF-infections or other problems related to
the surgery or their hydrocephalus. The study team will examine these results and determine
if ETV is a safer or more effective treatment for children with communicating hydrocephalus
than is a ventricular shunt.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment