The CSF Shunt Entry Site Trial
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ClinicalTrials.gov Identifier: NCT02425761 |
Recruitment Status : Unknown
Verified November 2020 by William Whitehead, Baylor College of Medicine.
Recruitment status was: Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : November 12, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hydrocephalus | Procedure: Ventriculoperitoneal shunt insertion surgery | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 448 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 1 to 1 randomized trial comparing two commonly used shunt insertion entry sites. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Adjudication committee reviews blinded notes, data collection forms, and films to determine shunt failure. |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion |
Actual Study Start Date : | April 1, 2015 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Anterior Entry SIte
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. |
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. |
Active Comparator: Posterior Entry Site
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. |
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. |
- Shunt Failure determined by clinical and radiographic findings [ Time Frame: Within 18 months to 44 months from shunt insertion surgery ]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).
- Patient quality of life measured by the Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 1 week and 1 year after shunt surgery ]A validated quality of life measure will be administered to all subjects/ caretakers at enrollment and at the above time intervals.
- Duration of surgery (minutes) [ Time Frame: Shunt insertion surgery ]
- Location of ventricular catheter tip on brain imaging [ Time Frame: within 1 year of shunt surgery ]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.
- Number and type of shunt revisions [ Time Frame: Within 18 months to 44 months from shunt insertion surgery ]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.

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Ages Eligible for Study: | 1 Day to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425761
United States, Alabama | |
Children's Hospital of Alabama | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Colorado | |
Children's Hospital Colorado | |
Denver, Colorado, United States, 80045 | |
United States, Maryland | |
Johns Hopkins Children's Center | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
St. Louis Children's Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15224 | |
United States, Tennessee | |
Monroe Carell Jr Children's Hospital at Vanderbilt | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Primary Children's Medical Center | |
Salt Lake City, Utah, United States, 84113 | |
United States, Washington | |
Seattle Children's Hospital | |
Seattle, Washington, United States, 98105 | |
Canada, Alberta | |
Alberta Children's Hospital | |
Calgary, Alberta, Canada, T3B 6A8 | |
Canada, British Columbia | |
BC Children's Hospital | |
Vancouver, British Columbia, Canada, V6H 3V4 | |
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | William E Whitehead, MD | Baylor College of Medicine | |
Study Chair: | John Kestle, MD | University of Utah |
Responsible Party: | William Whitehead, Professor, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT02425761 |
Other Study ID Numbers: |
H-35639 |
First Posted: | April 24, 2015 Key Record Dates |
Last Update Posted: | November 12, 2020 |
Last Verified: | November 2020 |
Cerebrospinal Fluid Shunts Randomized Controlled Trial |
Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases |