HydrocephalusPhase 3NCT02425761
The CSF Shunt Entry Site Trial
A Phase 3 study testing Ventriculoperitoneal shunt insertion surgery in people with Hydrocephalus, run by Baylor College of Medicine at 14 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Ventriculoperitoneal shunt insertion surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 1 Apr 2015to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States11 sites
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital Colorado
Denver, Colorado, 80045
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
Canada3 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion
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.
Read the 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.
- Conditions
- Hydrocephalus
- Being tested
- Ventriculoperitoneal shunt insertion surgery
- Keywords
- Cerebrospinal Fluid Shunts, Randomized Controlled Trial
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriculoperitoneal shunt insertion surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ventriculoperitoneal shunt insertion surgery |
| 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. Receives: Procedure: Ventriculoperitoneal shunt insertion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 18 months to 44 months from shunt insertion surgery
Secondary outcomes (4)
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.
Measured: 1 week and 1 year after shunt surgery
Duration of surgery (minutes)
Measured: 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.
Measured: 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.
Measured: Within 18 months to 44 months from shunt insertion surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start1 Apr 2015
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 to 1 randomized trial comparing two commonly used shunt insertion entry sites.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham, University of British Columbia, University of Pittsburgh, University of Toronto, University of Utah, University of Washington, Vanderbilt University, Washington University School of Medicine, Hydrocephalus Association, Ohio State University, Johns Hopkins University, University of Calgary, University of Colorado, Denver, University of Southern California
- Responsible party
- Principal investigator, William Whitehead, Baylor College of Medicine
- Investigators
- William E Whitehead, MD, Principal investigator, Baylor College of MedicineJohn Kestle, MD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425761
- Sponsor's protocol ID
- H-35639
- Status last verified
- Nov 2020
- First submitted
- 20 Apr 2015
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion
- ClinicalTrials.gov ID
- NCT02425761
- Acronym / sponsor ID
- H-35639
- Conditions
- Hydrocephalus
- Keywords
- Cerebrospinal Fluid Shunts, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham, University of British Columbia, University of Pittsburgh, University of Toronto, University of Utah, University of Washington, Vanderbilt University, Washington University School of Medicine, Hydrocephalus Association, Ohio State University, Johns Hopkins University, University of Calgary, University of Colorado, Denver, University of Southern California
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1 to 1 randomized trial comparing two commonly used shunt insertion entry sites.
| Arm | Type | Receives |
|---|---|---|
| Anterior Entry SIte | Active comparator | Procedure: Ventriculoperitoneal shunt insertion surgeryAnterior 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. |
| Posterior Entry Site | Active comparator | Procedure: Ventriculoperitoneal shunt insertion surgeryPosterior 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. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventriculoperitoneal shunt insertion surgeryThe 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. | Procedure or surgery | Anterior Entry SIte, Posterior Entry Site |
Primary outcome
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).
4 secondary outcomes
Patient quality of life measured by the Pediatric Quality of Life Inventory (PedsQL)
Time frame: 1 week and 1 year after shunt surgery
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
Number and type of shunt revisions
Time frame: Within 18 months to 44 months from shunt insertion surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Hydrocephalus Clinical Research Network WebsiteLink provided by the sponsor.
- Hydrocephalus Association WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Whitehead, MD principal investigator
Baylor College of Medicine
John Kestle, MD study chair
University of Utah
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ventriculoperitoneal shunt insertion surgery in people with Hydrocephalus, run by Baylor College of Medicine at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shunt Failure determined by clinical and radiographic findings (time frame: Within 18 months to 44 months from shunt insertion surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.