Third Ventriculostomy Versus Shunt for Children With Hydrocephalus

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Duke University
Sponsor:
Collaborator:
Pediatric Hydrocephalus Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01801267
First received: February 26, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Communicating Hydrocephalus
Procedure: Endoscopic third ventriculostomy (ETV)
Procedure: Ventricular shunt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Time until need for further CSF-related surgeries [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Total number of CSF-related surgeries needed within one year [ Time Frame: one year ] [ Designated as safety issue: No ]
    The measurement will be the total number of CSF-related surgeries that a patient requires within one year of their initial randomized study surgery.


Other Outcome Measures:
  • Morbidities [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The measurement will be the percentage of patients who suffer CSF-infections or other problems related to the surgery or their hydrocephalus within one year after their initial randomized surgery.

  • Time spent in the hospital [ Time Frame: one year ] [ Designated as safety issue: No ]
    The measurement will be how much time patients in each group spend in the hospital during the one year after their initial randomized surgery.


Estimated Enrollment: 130
Study Start Date: August 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic third ventriculostomy (ETV)
Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV).
Procedure: Endoscopic third ventriculostomy (ETV)
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.
Other Names:
  • ETV
  • third ventriculostomy
Active Comparator: Ventricular shunt
Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision.
Procedure: Ventricular shunt
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.
Other Names:
  • VP shunt
  • VA shunt
  • ventriculoperitoneal shunt
  • ventriculoatrial shunt
  • ventriculopleural shunt

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801267

Contacts
Contact: Carrie R Muh, MD, MS 919-684-5013 ext 3

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Pediatric Hydrocephalus Foundation
Investigators
Principal Investigator: Carrie R Muh, MD, MS Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01801267     History of Changes
Other Study ID Numbers: Pro00043098
Study First Received: February 26, 2013
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Hydrocephalus
Pediatric
Ventricular shunt
Ventriculoperitoneal shunt
Third ventriculostomy
Randomized controlled trial

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on July 29, 2014