The CSF Shunt Entry Site Trial

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

Interventions

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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Hydrocephalus Association

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• William E Whitehead, MD · Baylor College of Medicine

• John Kestle, MD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-01

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• United States
• Canada

Study Locations