The CSF Shunt Entry Site Trial

Study Description

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Brief 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. 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 or disease	Intervention/treatment	Phase
Hydrocephalus	Procedure: Ventriculoperitoneal shunt insertion surgery	Phase 3

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	448 participants
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
Study Start Date :	April 2015
Estimated Primary Completion Date :	November 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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.
2. Duration of surgery (minutes) [ Time Frame: Shunt insertion surgery ]
3. 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.
4. 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.

Eligibility Criteria

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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

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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	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
Saint 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

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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Hydrocephalus Clinical Research Network Website 

Hydrocephalus Association Website 

Responsible Party:	William Whitehead, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT02425761 History of Changes
Other Study ID Numbers:	CER-1403-13857
First Posted:	April 24, 2015
Last Update Posted:	December 21, 2017
Last Verified:	December 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