Clinical trial NCT02425761: The CSF Shunt Entry Site Trial
Official title: A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hydrocephalus
Keywords: Cerebrospinal Fluid Shunts
Randomized Controlled Trial
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Alabama at Birmingham
name: University of British Columbia
name: University of Pittsburgh
name: University of Toronto
name: University of Utah
name: University of Washington
name: Vanderbilt University
name: Washington University School of Medicine
name: Hydrocephalus Association
name: Ohio State University
name: Johns Hopkins University
name: University of Calgary
name: University of Colorado, Denver
name: University of Southern California
First posted: 2015-04-24
Enrollment: 448
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 to 1 randomized trial comparing two commonly used shunt insertion entry sites.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study is a multi-centered, randomized, controlled trial comparing two commonly used CSF shunt insertion techniques, anterior and posterior entry site. There is conflicting information and opinions in the pediatric hydrocephalus literature regarding entry site's effect on shunt survival. This trial is designed to detect a 10% or more difference in the rate of shunt survival at one year between the two techniques.

The trial will be conducted by the Hydrocephalus Clinical Research Network and the Hydrocephalus Association. It is a four year study with an estimated sample size of 448 patients. Patients will be randomized in the operating room. Subjects will be followed for a minimum of 18 months.

Eligibility criteria: Inclusion Criteria:

1. Less than 18 years of age at the time of shunt insertion; AND
2. Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt as determined by a pediatric neurosurgeon; AND
3. 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
4. Ventriculomegaly on imaging.

Exclusion Criteria:

1. 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.
2. Active CSF or abdominal infection;
3. CSF leak without hydrocephalus;
4. Pseudotumor cerebri;
5. Hydranencephaly;
6. 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;
7. 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);
8. A bilateral scalp, bone, or ventricular lesion that makes placement of either an anterior or a posterior shunt impracticable (e.g. cutis aplasia);
9. Bilateral slit like frontal horns or trigones defined as the widest distance between the medial and lateral walls less than 3 millimeters.
10. 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.

Primary outcomes:
measure: Shunt Failure determined by clinical and radiographic findings
timeFrame: Within 18 months to 44 months from shunt insertion surgery
Secondary outcomes:
measure: Patient quality of life measured by the Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 1 week and 1 year after shunt surgery
measure: Duration of surgery (minutes)
timeFrame: Shunt insertion surgery
measure: Location of ventricular catheter tip on brain imaging
timeFrame: within 1 year of shunt surgery
measure: Number and type of shunt revisions
timeFrame: Within 18 months to 44 months from shunt insertion surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Baylor College of Medicine
name: William E Whitehead, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: John Kestle, MD
role: STUDY_CHAIR
References: