Third Ventriculostomy Versus Shunt for Children With Hydrocephalus

NCT01801267 | Completed

• 1 other identifier: Pro00043098
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Ventriculoperitoneal shunts are the standard of care for patients with communicating hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail within 2 years. It has long been assumed that endoscopic third ventriculostomy (ETV) would not work in this population and is better suited to patients with obstructive hydrocephalus (such as from a tumor blocking cerebral-spinal fluid (CSF) pathways). However, as scientists learn more about CSF and the way our brains absorb this fluid, they have learned that this may not be so straight-forward. Recent small studies have shown that ETVs can work in a good percentage of children with communicating hydrocephalus, too. But no randomized controlled trials have been done to compare these two treatments directly to determine which will provide children with a better prognosis, fewer surgeries over their lifetime, less time in the hospital and the greatest chance at as normal a life as possible. The investigators will conduct a trial to compare these two surgical treatments where patients will be randomized to receive either a shunt or an ETV. Because ETV has been shown to have a high failure rate in newborns, the investigators will not include these patients and instead will study patients who come to Duke University with communicating hydrocephalus between the ages of 1 year and 18 years. The study will include patients with ventricular shunts who are in need of revision and patients who were just diagnosed and need their first shunt. All patients who agree to participate will be randomized to receive either an ETV or a shunt. The study team will follow them for one year from the time of the surgery and will determine what percentage of patients require further CSF-related surgeries, how long they go after their surgery before they need another surgery, how much time they spend in the hospital and what percentage of patients suffer CSF-infections or other problems related to the surgery or their hydrocephalus. The study team will examine these results and determine if ETV is a safer or more effective treatment for children with communicating hydrocephalus than is a ventricular shunt.

Conditions

Communicating Hydrocephalus

Keywords

Hydrocephalus; Pediatric; Ventricular shunt; Ventriculoperitoneal shunt; Third ventriculostomy; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Time until need for further CSF-related surgeries

  The measurement will be the time between the initial randomized study surgery and any additional CSF-related surgery that the patient needs for a maximum of one year.

  one year

Secondary Outcomes (1)

• Total number of CSF-related surgeries needed within one year

  one year

Other Outcomes (2)

• Morbidities

  one year

• Time spent in the hospital

  one year

Study Arms (2)

Endoscopic third ventriculostomy (ETV)

EXPERIMENTAL

Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV).

Procedure: Endoscopic third ventriculostomy (ETV)

Ventricular shunt

ACTIVE COMPARATOR

Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision.

Procedure: Ventricular shunt

Interventions

Endoscopic third ventriculostomy (ETV) PROCEDURE

Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV). A neurosurgeon will make a small hole in the third ventricle (a fluid space in the brain) to allow CSF to flow out of the ventricles.

Also known as: ETV, third ventriculostomy

Endoscopic third ventriculostomy (ETV)

Ventricular shunt PROCEDURE

Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision. A neurosurgeon will insert a small tube into the ventricle (a fluid space in the brain) and connect this tube to another location in the body so that CSF can flow out of the brain and be absorbed elsewhere in the body - the belly, the top of the heart or the side of the lung. If a patient already has a shunt which is not working, a neurosurgeon will fix or replace it. This will serve as the Control arm of the study.

Also known as: VP shunt, VA shunt, ventriculoperitoneal shunt, ventriculoatrial shunt, ventriculopleural shunt

Ventricular shunt

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children age 1-18 years
• Patients with communicating hydrocephalus who present in need of CSF diversion surgery, as diagnosed by radiographic imaging (CT or MRI of brain) as well as clinical signs or symptoms of increased intracranial pressure
• Informed consent according to institutional guidelines must be obtained from each patient's parent or legal guardian, or by the patient him/herself if he/she is 18 years of age

You may not qualify if:

• An active Central Nervous System malignancy (cancer)
• The presence of two or more current ventricular catheters indicating that the ventricles do not communicate with each other
• The inability of the parent/guardian or patient to provide informed consent

Sponsors & Collaborators

• Duke University: lead
• Pediatric Hydrocephalus Foundation: collaborator
• Children's Miracle Network Hospitals: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Interventions

Ventriculostomy; Cerebrospinal Fluid Shunts; Ventriculoperitoneal Shunt

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Carrie R Muh, MD, MS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)