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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Alabama at Birmingham | OTHER |
| University of British Columbia | OTHER |
| University of Pittsburgh |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Entry SIte | Active Comparator | Anterior entry site is defined as shunt surgery with catheter entry into the brain from an opening near the coronal suture, on the top of the head and near the front. Specifically, anterior entry is defined as ventricular catheter entry less than 1 centimeter anterior to the coronal suture near the mid-pupillary line. Subjects randomized to this arm will undergo ventriculoperitoneal shunt insertion surgery using an anterior entry site. |
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| Posterior Entry Site | Active Comparator | Posterior entry site is defined as shunt surgery with catheter entry into the brain from an opening near the lambdoid suture, on the back of the head. Specifically, posterior entry is defined as ventricular catheter entry 4 to 7 centimeters above the external occipital protuberance (inion), near the mid-pupillary line. Subjects randomized to this arm will undergo ventriculoperitoneal shunt insertion surgery using a posterior entry site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventriculoperitoneal shunt insertion surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of surgery (minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William E Whitehead, MD | Baylor College of Medicine | Principal Investigator |
| John Kestle, MD | University of Utah | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital of Los Angeles |
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| Label | URL |
|---|---|
| Hydrocephalus Clinical Research Network Website | View source |
| Hydrocephalus Association Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 21, 2020 | |
| Reset | Jan 13, 2021 | |
| Release | Sep 9, 2025 | |
| Reset | Sep 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 21, 2020 | Jan 13, 2021 | |||
| Sep 9, 2025 |
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| University of Toronto | OTHER |
| University of Utah | OTHER |
| University of Washington | OTHER |
| Vanderbilt University | OTHER |
| Washington University School of Medicine | OTHER |
| Hydrocephalus Association | OTHER |
| Ohio State University | OTHER |
| Johns Hopkins University | OTHER |
| University of Calgary | OTHER |
| University of Colorado, Denver | OTHER |
| University of Southern California | OTHER |
1 to 1 randomized trial comparing two commonly used shunt insertion entry sites.
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Adjudication committee reviews blinded notes, data collection forms, and films to determine shunt failure.
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| Shunt insertion surgery |
| 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 |
| 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 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Children's Hospital Colorado | Denver | Colorado | 80045 | United States |
| Johns Hopkins Children's Center | Baltimore | Maryland | 21287 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Monroe Carell Jr Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| BC Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Sep 30, 2025 |