Third Ventriculostomy Versus Shunt for Children With Hydrocephalus
Condition: Communicating Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Endoscopic third ventriculostomy (ETV); Ventricular shunt
Intervention type(s): Procedure; Procedure
Intervention description(s): Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV). A neurosurgeon will make a small hole in the third ventricle (a fluid space in the brain) to allow CSF to flow out of the ventricles.; Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision. A neurosurgeon will insert a small tube into the ventricle (a fluid space in the brain) and connect this tube to another location in the body so that CSF can flow out of the brain and be absorbed elsewhere in the body - the belly, the top of the heart or the side of the lung. If a patient already has a shunt which is not working, a neurosurgeon will fix or replace it. This will serve as the Control arm of the study.
Other intervention name(s): ETV; third ventriculostomy; VP shunt; VA shunt; ventriculoperitoneal shunt; ventriculoatrial shunt; ventriculopleural shunt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydrocephalus; Pediatric; Ventricular shunt; Ventriculoperitoneal shunt; Third ventriculostomy; Randomized controlled trial