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The CSF Shunt Entry Site Trial

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by William Whitehead, Baylor College of Medicine
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
ClinicalTrials.gov Identifier:
NCT02425761
First received: April 20, 2015
Last updated: April 15, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Hydrocephalus Procedure: Ventriculoperitoneal shunt insertion surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion

Resource links provided by NLM:


Further study details as provided by William Whitehead, Baylor College of Medicine:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 448
Study Start Date: April 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02425761

Contacts
Contact: Vanessa Wall (801) 662-5343 vanessa.l.wall@hsc.utah.edu
Contact: Marcie Langley (801) 662-5364 marcie.langley@hsc.utah.edu

Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Anastasia Arynchyna, MPH    205-638-9653    arynch@uab.edu   
Contact: Curtis Rozzelle, MD    205-638-9653    Curtis.Rozzelle@childrensal.org   
United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Mark Krieger, MD       MKrieger@chla.usc.edu   
Contact: Christina Artime       cartime@chla.usc.edu   
United States, Colorado
Children's Hospital Colorado Not yet recruiting
Denver, Colorado, United States, 80045
Contact: Todd Hankinson, MD       Todd.Hankinson@childrenscolorado.org   
Contact: Susan Staulcup       SUSAN.STAULCUP@UCDENVER.EDU   
United States, Maryland
Johns Hopkins Children's Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Adam Loudermilk       alouder1@jhmi.edu   
Contact: Edward Ahn, MD       eahn4@jhmi.edu   
United States, Missouri
St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Diego Morales    314-454-2810    moralesd@wudosis.wustl.edu   
Contact: David Limbrick, MD    314-454-2810    limbrickd@wudosis.wustl.edu   
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jonathan Pindrik, MD       Jonathan.Pindrik@nationwidechildrens.org   
Contact: Adrienne Boczar       Adrienne.Boczar@nationwidechildrens.org   
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Kim Diamond    412-692-9965    harlankl@UPMC.EDU   
United States, Tennessee
Monroe Carell Jr Children's Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: Stephen R Gannon    615-936-6809    stephen.r.gannon@vanderbilt.edu   
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Sheila Martinez    832-822-3950    srmarti2@texaschildrens.org   
Contact: William E Whitehead, MD    832-822-3950    wewhiteh@texaschildrens.org   
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Jason Clawson, BA, CCRC    801-662-5369    jason.clawson@hsc.utah.edu   
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Gloria Bowen, RN    206-987-5916    gloria.bowen@seattlechildrens.org   
Contact: Amy Anderson, RN       amya9@uw.edu   
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Jay Riva-Cambrin, MD       Jay.Riva-Cambrin@hsc.utah.edu   
Contact: Salim Ahmed       salahmed@ucalgary.ca   
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Alexander Cheong    604-875-2345 ext 7132    alexander.cheong@cw.bc.ca   
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Homa Ashrafpour       homa.ashrafpour@sickkids.ca   
Sponsors and Collaborators
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
Investigators
Principal Investigator: William E Whitehead, MD Baylor College of Medicine
Study Chair: John Kestle, MD University of Utah
  More Information

Additional Information:
Responsible Party: William Whitehead, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02425761     History of Changes
Other Study ID Numbers: CER-1403-13857
Study First Received: April 20, 2015
Last Updated: April 15, 2017

Keywords provided by William Whitehead, Baylor College of Medicine:
Cerebrospinal Fluid Shunts
Randomized Controlled Trial

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 21, 2017