The CSF Shunt Entry Site Trial

• ClinicalTrials.gov Identifier: NCT02425761
• Recruitment Status: Active, not recruiting
• First Posted: April 24, 2015
• Last Update Posted: March 26, 2019
• Sponsor: Baylor College of Medicine
• 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

Study Description

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

• 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: July 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

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

• 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

Locations

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

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:

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: March 26, 2019
• Last Verified: March 2019

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