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The CSF Shunt Entry Site Trial

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ClinicalTrials.gov Identifier: NCT02425761
Recruitment Status : Recruiting
First Posted : April 24, 2015
Last Update Posted : December 21, 2017
Sponsor:
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
Information provided by (Responsible Party):
William Whitehead, Baylor College of Medicine

April 20, 2015
April 24, 2015
December 21, 2017
April 2015
November 2018   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT02425761 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The CSF Shunt Entry Site Trial
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Hydrocephalus
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: 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.

    Intervention: Procedure: Ventriculoperitoneal shunt insertion surgery
  • 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.

    Intervention: Procedure: Ventriculoperitoneal shunt insertion surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
448
Same as current
December 2018
November 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact: Vanessa Wall (801) 662-5343 vanessa.l.wall@hsc.utah.edu
Contact: Marcie Langley (801) 662-5364 marcie.langley@hsc.utah.edu
Canada,   United States
 
 
NCT02425761
CER-1403-13857
Yes
Not Provided
Not Provided
William Whitehead, Baylor College of Medicine
Baylor College of Medicine
  • 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
Principal Investigator: William E Whitehead, MD Baylor College of Medicine
Study Chair: John Kestle, MD University of Utah
Baylor College of Medicine
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP