The CSF Shunt Entry Site Trial

Status unconfirmed · Phase 3

Conditions studied: Hydrocephalus

In brief

The purpose of the study is to compare the survival time (time to first shunt failure) of ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted through a posterior entry site in children. Shunt entry site is the location on the head that the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the ventricles. Entry sites can be anterior or posterior.

Key facts

Study ID

NCT02425761

Run by

Baylor College of Medicine

People needed

448

Starts

2015-04-01

Expected to finish

2020-12-31

Last updated by the study team

2020-11-12

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Less than 18 years of age at the time of shunt insertion; AND
• Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt as determined by a pediatric neurosurgeon; AND
• No prior history of shunt insertion (a history of an external ventricular drain, ventricular reservoir, subgaleal shunt, and or endoscopic third ventriculostomy with or without choroid plexus coagulation is permissible); AND
• Ventriculomegaly on imaging.

You may not qualify if…

• Need of a shunt that is not a simple ventriculoperitoneal shunt. For example: Patients who require more than one intracranial catheter are excluded. Patients who require a ventricular shunt that terminates in the atrium of the heart, the pleural cavity, the gallbladder, or any other terminal location that is not the peritoneal cavity are excluded. Patients who require a subdural to peritoneal or a cyst to peritoneal shunt are excluded.
• Active CSF or abdominal infection;
• CSF leak without hydrocephalus;
• Pseudotumor cerebri;
• Hydranencephaly;
• Loculations within the ventricular system (e.g. large intraventricular cysts or ventricular adhesions which create compartments that distort the ventricular anatomy; isolated trapped lateral ventricle). A small cyst within the ventricle does not meet these criteria;
• Other difficulties that would preclude follow up at one year (e.g. terminal illness with life expectancy less than 18 months; family plans to move out of region or country);
• A bilateral scalp, bone, or ventricular lesion that makes placement of either an anterior or a posterior shunt impracticable (e.g. cutis aplasia);
• Bilateral slit like frontal horns or trigones defined as the widest distance between the medial and lateral walls less than 3 millimeters.
• Patient is scheduled to have an intra-ventricular procedure (e.g. ETV, endoscopic biopsy, arachnoid cyst fenestration, fenestration of septum pellucidum) in addition to possible or definite VP shunt.

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• Johns Hopkins Children's Center — Baltimore, Maryland, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Monroe Carell Jr Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada
• BC Children's Hospital — Vancouver, British Columbia, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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