The CSF Shunt Entry Site Trial

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02425761
• Other study ID #: H-35639
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 448
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Procedure:
• Ventriculoperitoneal shunt insertion surgery
The most common treatment for hydrocephalus is the placement of a ventriculoperitoneal shunt in the operating room. A shunt is a flexible tube placed into the ventricular system, fluid filled chambers, of the brain that diverts the flow of CSF into another region of the body, usually the abdomen, also known as the peritoneal cavity, where it can be absorbed.

Locations

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

Sponsors (16)

Lead Sponsor

Collaborator

Baylor College of Medicine

Hydrocephalus Association, Johns Hopkins University, Ohio State University, Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham, University of British Columbia, University of Calgary, University of Colorado, Denver, University of Pittsburgh, University of Southern California, University of Toronto, University of Utah, University of Washington, Vanderbilt University, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shunt Failure determined by clinical and radiographic findings	Shunt failure occurs when the shunt is obstructed, infected, over-drains, or does not drain the entire ventricular system. Shunt failure will be confirmed by radiographic and/ or operative findings, and all failures will be reviewed by a blinded adjudication committee. Subjects will be monitored for shunt failure at each scheduled and unscheduled clinical visit throughout the study. Survival analysis will be used to compare time to shunt failure in each treatment group. The last subject entered into the trial will be followed for 18 months and accrual is expected to take 26 months (maximum follow up 44 months).	Within 18 months to 44 months from shunt insertion surgery
Secondary	Patient quality of life measured by the Pediatric Quality of Life Inventory (PedsQL)	A validated quality of life measure will be administered to all subjects/ caretakers at enrollment and at the above time intervals.	1 week and 1 year after shunt surgery
Secondary	Duration of surgery (minutes)		Shunt insertion surgery
Secondary	Location of ventricular catheter tip on brain imaging	Position of the ventricular catheter on the first postoperative imaging study will be assessed on postoperative imaging studies obtained within 1 year of shunt insertion surgery. The frequency of catheter tips in poor locations (e.g. within brain parenchyma) will be compared between treatment groups.	within 1 year of shunt surgery
Secondary	Number and type of shunt revisions	The number of shunt revisions required by each subject from the time of shunt insertion to the conclusion of the study will be compared. All subjects will be followed for at least 18 months.	Within 18 months to 44 months from shunt insertion surgery

External Links

•   Hydrocephalus Association Website
•   Hydrocephalus Clinical Research Network Website