The CSF Shunt Entry Site Trial

NCT02425761 | Unknown Phase 3 DMC

• 1 other identifier: H-35639
• Study Type: interventional
• Target: 448
• Locations: 2 countries
• Sites: 14

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.

Conditions

Hydrocephalus

Keywords

Cerebrospinal Fluid Shunts; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  1 week and 1 year after shunt surgery

• Duration of surgery (minutes)

  Shunt insertion surgery

• Location of ventricular catheter tip on brain imaging

  within 1 year of shunt surgery

• Number and type of shunt revisions

  Within 18 months to 44 months from shunt insertion surgery

Study Arms (2)

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.

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.

Procedure: Ventriculoperitoneal shunt insertion surgery

Interventions

Ventriculoperitoneal shunt insertion surgery PROCEDURE

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.

Anterior Entry SIte; Posterior Entry Site

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Alabama at Birmingham: collaborator
• University of British Columbia: collaborator
• University of Pittsburgh: collaborator
• University of Toronto: collaborator
• University of Utah: collaborator
• University of Washington: collaborator
• Vanderbilt University: collaborator
• Washington University School of Medicine: collaborator
• Hydrocephalus Association: collaborator
• Ohio State University: collaborator
• Johns Hopkins University: collaborator
• University of Calgary: collaborator
• University of Colorado, Denver: collaborator
• University of Southern California: collaborator

Study Sites (14)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

• Hydrocephalus Clinical Research Network Website
• Hydrocephalus Association Website

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• William E Whitehead, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• John Kestle, MD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Adjudication committee reviews blinded notes, data collection forms, and films to determine shunt failure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1 to 1 randomized trial comparing two commonly used shunt insertion entry sites.

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

CA (3); US (11)