HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Summary

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.

Conditions

• Hydrocephalus

Interventions

PROCEDURE

Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)

Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.

DEVICE

Ventriculoperitoneal Shunt

The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Hydrocephalus Association

  collaborator OTHER

• Penn State University

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Baylor College of Medicine

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Orlando Health, Inc.

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• Trustees of Indiana University

  collaborator UNKNOWN

• University of Utah

  lead OTHER

Principal Investigators

• John Kestle, MD · University of Utah

• Abhaya Kulkarni, MD · University of Toronto

• David Limbrick, MD · Washington University School of Medicine

• Richard Holubkov, PhD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

104 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-21

Primary Completion

2027-05-30

Completion

2027-08-31

Countries

• United States
• Canada

Study Locations