NCT04177914

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 1 Day – 104 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

The ESTHI Trial is a multi-center randomized controlled trial (RCT) comparing endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC) and shunt in infants with hydrocephalus. The study will leverage the infrastructure of the Hydrocephalus Clinical Research Network (HCRN), a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome is the primary concern of families and will, therefore, be the primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these two treatments. The results of the RCT will help families determine the optimal treatment of hydrocephalus for their child.

Conditions

• Hydrocephalus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-21
• Primary completion: 2027-05-30
• Completion: 2027-08-31
• First posted: 2019-11-26
• Last updated: 2025-06-11

Locations

21 sites across 2 countries: United States, Canada