A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion
Background: Hydrocephalus (water on the brain) is a devastating long-term disease affecting 1 to 2 of every 1,000 babies born in the United States, making it as common as Down syndrome and more common than spina bifida or brain tumors. It occurs when the brain is unable to reabsorb cerebrospinal fluid (CSF) as quickly as it is produced, causing a fluid build-up that increases pressure on the brain. If left untreated, hydrocephalus can result in death. There is no cure for hydrocephalus, and only surgical treatments are available.
Placement of a CSF shunt is the most common treatment for hydrocephalus. The shunt, a flexible tube, is a surgically implanted into the fluid-filled chambers of the brain to divert the flow of CSF into another region of the body, usually the abdomen, where it can be absorbed.
Shunts experience a high failure rate due to obstruction, and approximately 50 percent fail within two years of surgical implantation. Shunt failure is a significant cause of pain, suffering, anxiety, and death in children.
The Hydrocephalus Clinical Research Network, an established network committed to improving the lives of children with hydrocephalus, working in cooperation with the Hydrocephalus Association, the largest patient advocacy group in the country, has identified a possible shunt survival advantage when shunts are implanted using an anterior entry site on the skull rather than a posterior entry site. This survival advantage may be due to better positioning of the catheter within the ventricle that minimizes scarring over time. This finding, although significant, is preliminary and needs more rigorous testing in the clinical setting before it can be adopted by neurosurgeons and generalized to all patients.
Method: This study will conduct a randomized controlled trial to compare the results of surgeries using the two entry sites.
Anticipated Impact: Improvement in shunt survival would result in a significant improvement in the lives of patients and families. Better, longer-lasting shunts would lower risks of shunt infection, partial or full shunt replacement, and death. Preventing shunt failure is an important goal. Improvements in shunt survival result in fewer hospitalizations, diagnostic tests, and days off from school and work. An answer to the entry site question will advance the field.