Communicating Hydrocephalus Clinical Trial
Official title:
A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus
| Verified date | March 2016 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 18 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | Children's Miracle Network Hospitals, Pediatric Hydrocephalus Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Morbidities | The measurement will be the percentage of patients who suffer CSF-infections or other problems related to the surgery or their hydrocephalus within one year after their initial randomized surgery. | one year | Yes |
| Other | Time spent in the hospital | The measurement will be how much time patients in each group spend in the hospital during the one year after their initial randomized surgery. | one year | No |
| Primary | Time until need for further CSF-related surgeries | The measurement will be the time between the initial randomized study surgery and any additional CSF-related surgery that the patient needs for a maximum of one year. | one year | No |
| Secondary | Total number of CSF-related surgeries needed within one year | The measurement will be the total number of CSF-related surgeries that a patient requires within one year of their initial randomized study surgery. | one year | No |