Third Ventriculostomy Versus Shunt for Children With Hydrocephalus

Not Applicable

Completed

• Conditions: Communicating Hydrocephalus
• Interventions: Procedure: Endoscopic third ventriculostomy (ETV); Procedure: Ventricular shunt

• Registration Number: NCT01801267
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Study Start: 2013-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic third ventriculostomy (ETV)	Endoscopic third ventriculostomy (ETV)	Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV).
Ventricular shunt	Ventricular shunt	Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision.

Primary Outcome Measures

Name	Time	Method
Time until need for further CSF-related surgeries	one year	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.

Secondary Outcome Measures

Name	Time	Method
Total number of CSF-related surgeries needed within one year	one year	The measurement will be the total number of CSF-related surgeries that a patient requires within one year of their initial randomized study surgery.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States