Clinical trial NCT01801267: Third Ventriculostomy Versus Shunt for Children With Hydrocephalus
Official title: A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communicating Hydrocephalus
Keywords: Hydrocephalus
Pediatric
Ventricular shunt
Ventriculoperitoneal shunt
Third ventriculostomy
Randomized controlled trial
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pediatric Hydrocephalus Foundation
name: Children's Miracle Network Hospitals
First posted: 2013-02-28
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Children age 1-18 years
* Patients with communicating hydrocephalus who present in need of CSF diversion surgery, as diagnosed by radiographic imaging (CT or MRI of brain) as well as clinical signs or symptoms of increased intracranial pressure
* Informed consent according to institutional guidelines must be obtained from each patient's parent or legal guardian, or by the patient him/herself if he/she is 18 years of age

Exclusion Criteria:

* An active Central Nervous System malignancy (cancer)
* The presence of two or more current ventricular catheters indicating that the ventricles do not communicate with each other
* The inability of the parent/guardian or patient to provide informed consent

Primary outcomes:
measure: Time until need for further CSF-related surgeries
timeFrame: one year
Secondary outcomes:
measure: Total number of CSF-related surgeries needed within one year
timeFrame: one year
Other outcomes:
measure: Morbidities
timeFrame: one year
measure: Time spent in the hospital
timeFrame: one year
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Carrie R Muh, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: