Communicating HydrocephalusNCT01801267
Third Ventriculostomy Versus Shunt for Children With Hydrocephalus
A study testing Endoscopic third ventriculostomy (ETV) and Ventricular shunt in people with Communicating Hydrocephalus, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Communicating Hydrocephalus
- What is being tested?
- Endoscopic third ventriculostomy (ETV) and Ventricular shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus
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
- Being tested
- Endoscopic third ventriculostomy (ETV), Ventricular shunt
- Keywords
- Hydrocephalus, Pediatric, Ventricular shunt, Ventriculoperitoneal shunt, Third ventriculostomy, Randomized controlled trial
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic third ventriculostomy (ETV)Procedure or surgery
Also called ETV, third ventriculostomy
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.
Ventricular shuntProcedure or surgery
Also called VP shunt, VA shunt, ventriculoperitoneal shunt, ventriculoatrial 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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic third ventriculostomy (ETV) | Experimental | Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV). Receives: Procedure: Endoscopic third ventriculostomy (ETV) |
| Ventricular shunt | Active comparator | Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision. Receives: Procedure: Ventricular shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Total number of CSF-related surgeries needed within 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communicating HydrocephalusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Hydrocephalus Foundation, Children's Miracle Network Hospitals
- Responsible party
- Sponsor
- Investigators
- Carrie R Muh, MD, MS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801267
- Sponsor's protocol ID
- Pro00043098
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Endoscopic Third Ventriculostomy Versus Ventricular Shunt for Children With Communicating Hydrocephalus
- ClinicalTrials.gov ID
- NCT01801267
- Acronym / sponsor ID
- Pro00043098
- Conditions
- Communicating Hydrocephalus
- Keywords
- Hydrocephalus, Pediatric, Ventricular shunt, Ventriculoperitoneal shunt, Third ventriculostomy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pediatric Hydrocephalus Foundation, Children's Miracle Network Hospitals
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic third ventriculostomy (ETV) | Experimental | Procedure: Endoscopic third ventriculostomy (ETV)Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV). |
| Ventricular shunt | Active comparator | Procedure: Ventricular shuntPediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic third ventriculostomy (ETV)Also: ETV, third ventriculostomyPediatric 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. | Procedure or surgery | Endoscopic third ventriculostomy (ETV) |
| Ventricular shuntAlso: VP shunt, VA shunt, ventriculoperitoneal shunt, ventriculoatrial shuntPediatric 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. | Procedure or surgery | Ventricular shunt |
Primary outcome
Time until need for further CSF-related surgeries
Time frame: 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.
1 secondary outcome
Total number of CSF-related surgeries needed within one year
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Communicating Hydrocephalus
Active, not recruiting
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
Hydrocephalus, Communicating, Hydrocephalus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie R Muh, MD, MS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic third ventriculostomy (ETV) and Ventricular shunt in people with Communicating Hydrocephalus, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until need for further CSF-related surgeries (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.