Hydrocephalus – Alternate Shunt Insertion Comparison

A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for CSF Shunt Insertion

Protocol Description

Through this multi-center study of the Patient-Centered Outcomes Research Institute (PCORI), researchers will compare results of two commonly used entry sites for shunt placement in the treatment of hydrocephalus. Hydrocephalus occurs when cerebrospinal fluid (CSF) is produced faster than the brain can absorb it, creating pressure on the brain that can lead to problems in growth and development. A shunt is a small plastic tube that is placed through incisions on the scalp into the fluid-filled ventricles of the brain. The shunt drains excess CFS, which is then absorbed elsewhere in the body. In the United States, pediatric surgeons insert the shunt either through the back of the skull (posterior) or a point closer to the front (anterior), but it is unclear whether one point is better than the other.

Eligibility Criteria

This study is enrolling boys and girls through age 17 who are having their first shunt placement for treatment of hydrocephalus.
Males and Females: Through age 17

Requirements

Through random selection the anterior or posterior entry site will be determined for each child entered into the study. Beyond data collection, there are no special procedures associated with this study. Follow up visits will occur as prescribed and an imaging study of the brain will be done within 14 months of shunt surgery to check its placement and re-evaluate size of the ventricles. Participants will be followed for 18 months, and some up to 4 years, depending on age at the time of enrollment.
Visits: None beyond normal clinical care
Duration: Up to 4 years

Status: Open to Enrollment

Source(s) of Support

Patient-Centered Outcomes Research Institute
Hydrocephalus Clinical Research Network
Hydrocephalus Association

Primary Investigator

Ian Pollack, MD

Contact Information

For more information about the study or enrollment, please contact:
Kimberly Diamond, BS, BA
412-692-9965