Third Ventriculostomy Versus Shunt for Children With Hydrocephalus
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|ClinicalTrials.gov Identifier: NCT01801267|
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : March 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Communicating Hydrocephalus||Procedure: Endoscopic third ventriculostomy (ETV) Procedure: Ventricular shunt||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Endoscopic third ventriculostomy (ETV)
Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV).
Procedure: Endoscopic third ventriculostomy (ETV)
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.
Active Comparator: Ventricular shunt
Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision.
Procedure: Ventricular shunt
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.
- Time until need for further CSF-related surgeries [ Time Frame: one year ]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.
- Total number of CSF-related surgeries needed within one year [ Time Frame: 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.
- Morbidities [ Time Frame: one year ]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.
- Time spent in the hospital [ Time Frame: one year ]The measurement will be how much time patients in each group spend in the hospital during the one year after their initial randomized surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801267
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Carrie R Muh, MD, MS||Duke University|