HydrocephalusNCT05534659
Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies
An observational study of Hydrocephalus and Ventriculoperitoneal Shunt Malfunction, run by Chang Gung Memorial Hospital.
Trial summary
Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephalus, Ventriculoperitoneal Shunt Malfunction
- What is being tested?
- Programmable valve and Non-programmable valve
- Type of treatment
- Medical device
- How many people
- 325 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Jul 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients who received CSF ventricular shunting operations at Chang Gung Medical Foundation, Linkou Branch, a tertiary medical center in northern Taiwan, would be included in the study.
Who may be able to join
- received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01~2017/12/31
Who cannot join
- Patients who received index ventricular CSF shunt at other hospitals,
- Patients who received index ventricular CSF shunt before January 1st 2017,
- Patients who were younger than 18
About this study
Official title: Comparison of Benefit and Survival for Different Etiologies of Adult Patients With Hydrocephalus Between Programmable Cerebrospinal Fluid Ventricular Shunt and Non-programmable Cerebrospinal Fluid Ventricular Shunt
Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.
Read the detailed description
Relatively high revision rates up to 32% of CSF shunting operations remained an unsolved problem for neurosurgeons. The cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.
The investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular CSF shunt operations conducted at a single institution in northern Taiwan from January 2017 to December 2017. Patients included in the study were followed up for at least five years. Statistical tests including independent t-test, Chi-square test and Fisher's exact test were used for comparative analysis, and Kaplan-Meier curve using log-rank test was performed to compare the revision-free survival between the PV and NPV groups
- Being tested
- Programmable valve, Non-programmable valve
- Keywords
- Hydrocephalus, Programmable shunt, Long-term outcome
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmable valveDevice
Programmable valve used in the study included Medtronic Strata, B-Braun ProGav, Codman Certas.
Non-programmable valveDevice
Non-programmable valve used in the study was Medtronic CSF-flow control valve.
| Study group | Role | What they receive |
|---|---|---|
| Programmable valve(PV) group | Adult patients with hydrocephalus who received programmable ventricular CSF shunts operation. Receives: Device: Programmable valve | |
| Non-programmable valve(NPV) group | Adult patients with hydrocephalus who received non-programmable ventricular CSF shunts operation. Receives: Device: Non-programmable valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Shunt revision rate
the ratio of the total number of patients with at least one revision to the total number of patients included in this study
Measured: since the time of index operation until the initial revision or 2022/07/31
Total Shunt revision rate
the ratio of the total number of revisions to the total number of ventricular CSF shunt operations
Measured: since the time of index operation until the initial revision or 2022/07/31
The cause of shunt revision
the cause of the shunt malfunction warranting revision operation
Measured: since the time of index operation until the initial revision or 2022/07/31
Type of the revision operation
the detailed description of the revision operation
Measured: since the time of index operation until the initial revision or 2022/07/31
Revision-free survival
the interval between index operation and the initial revision
Measured: since the time of index operation until the initial revision or 2022/07/31
Secondary outcomes (1)
Shunt revision-free survival among different hydrocephalus etiologies
the individual interval between index operation and the initial revision among different hydrocephalus etiologies
Measured: since the time of index operation until the initial revision or 2022/07/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Jan 2017
- Primary completion1 Mar 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- ZHUO HAO Liu, PhD, Principal investigator, Department of Neurosurgery Chang Gung Memorial Hospital Chang Gung Medical College and University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534659
- Sponsor's protocol ID
- 202200775B0
- Status last verified
- Aug 2022
- First submitted
- 6 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Li M, Wang H, Ouyang Y, Yin M, Yin X. Efficacy and safety of programmable shunt valves for hydrocephalus: A meta-analysis. Int J Surg. 2017 Aug;44:139-146. doi: 10.1016/j.ijsu.2017.06.078. Epub 2017 Jun 22.
PubMed 28648796Rinaldo L, Bhargav AG, Nesvick CL, Lanzino G, Elder BD. Effect of fixed-setting versus programmable valve on incidence of shunt revision after ventricular shunting for idiopathic normal pressure hydrocephalus. J Neurosurg. 2019 Jun 7;133(2):564-572. doi: 10.3171/2019.3.JNS183077. Print 2020 Aug 1.
PubMed 31174190Reddy GK, Bollam P, Shi R, Guthikonda B, Nanda A. Management of adult hydrocephalus with ventriculoperitoneal shunts: long-term single-institution experience. Neurosurgery. 2011 Oct;69(4):774-80; discussion 780-1. doi: 10.1227/NEU.0b013e31821ffa9e.
PubMed 21508873
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Benefit and Survival for Different Etiologies of Adult Patients With Hydrocephalus Between Programmable Cerebrospinal Fluid Ventricular Shunt and Non-programmable Cerebrospinal Fluid Ventricular Shunt
- ClinicalTrials.gov ID
- NCT05534659
- Acronym / sponsor ID
- 202200775B0
- Keywords
- Hydrocephalus, Programmable shunt, Long-term outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 9 Sep 2022 (actual)
- 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.
Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.
Detailed description
Relatively high revision rates up to 32% of CSF shunting operations remained an unsolved problem for neurosurgeons. The cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.
The investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular CSF shunt operations conducted at a single institution in northern Taiwan from January 2017 to December 2017. Patients included in the study were followed up for at least five years. Statistical tests including independent t-test, Chi-square test and Fisher's exact test were used for comparative analysis, and Kaplan-Meier curve using log-rank test was performed to compare the revision-free survival between the PV and NPV groups
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programmable valve(PV) group | – | Device: Programmable valveAdult patients with hydrocephalus who received programmable ventricular CSF shunts operation. |
| Non-programmable valve(NPV) group | – | Device: Non-programmable valveAdult patients with hydrocephalus who received non-programmable ventricular CSF shunts operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who received CSF ventricular shunting operations at Chang Gung Medical Foundation, Linkou Branch, a tertiary medical center in northern Taiwan, would be included in the study.
Key inclusion criteria (1 listed)
- received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01~2017/12/31
Key exclusion criteria (3 listed)
- Patients who received index ventricular CSF shunt at other hospitals,
- Patients who received index ventricular CSF shunt before January 1st 2017,
- Patients who were younger than 18
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 |
|---|---|---|
| Programmable valveProgrammable valve used in the study included Medtronic Strata, B-Braun ProGav, Codman Certas. | Device | Programmable valve(PV) group |
| Non-programmable valveNon-programmable valve used in the study was Medtronic CSF-flow control valve. | Device | Non-programmable valve(NPV) group |
Primary outcome
Initial Shunt revision rate
Time frame: since the time of index operation until the initial revision or 2022/07/31
the ratio of the total number of patients with at least one revision to the total number of patients included in this study
Total Shunt revision rate
Time frame: since the time of index operation until the initial revision or 2022/07/31
the ratio of the total number of revisions to the total number of ventricular CSF shunt operations
The cause of shunt revision
Time frame: since the time of index operation until the initial revision or 2022/07/31
the cause of the shunt malfunction warranting revision operation
Type of the revision operation
Time frame: since the time of index operation until the initial revision or 2022/07/31
the detailed description of the revision operation
Revision-free survival
Time frame: since the time of index operation until the initial revision or 2022/07/31
the interval between index operation and the initial revision
1 secondary outcome
Shunt revision-free survival among different hydrocephalus etiologies
Time frame: since the time of index operation until the initial revision or 2022/07/31
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 16 Sep 2022.
- Background: PubMed 28648796Li M, Wang H, Ouyang Y, Yin M, Yin X. Efficacy and safety of programmable shunt valves for hydrocephalus: A meta-analysis. Int J Surg. 2017 Aug;44:139-146. doi: 10.1016/j.ijsu.2017.06.078. Epub 2017 Jun 22.
- Background: PubMed 31174190Rinaldo L, Bhargav AG, Nesvick CL, Lanzino G, Elder BD. Effect of fixed-setting versus programmable valve on incidence of shunt revision after ventricular shunting for idiopathic normal pressure hydrocephalus. J Neurosurg. 2019 Jun 7;133(2):564-572. doi: 10.3171/2019.3.JNS183077. Print 2020 Aug 1.
- Background: PubMed 21508873Reddy GK, Bollam P, Shi R, Guthikonda B, Nanda A. Management of adult hydrocephalus with ventriculoperitoneal shunts: long-term single-institution experience. Neurosurgery. 2011 Oct;69(4):774-80; discussion 780-1. doi: 10.1227/NEU.0b013e31821ffa9e.
- Individual participant dataSharing planned: Undecided
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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.
ZHUO HAO Liu, PhD principal investigator
Department of Neurosurgery Chang Gung Memorial Hospital Chang Gung Medical College and University
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and Ventriculoperitoneal Shunt Malfunction, run by Chang Gung Memorial Hospital.
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 1 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Initial Shunt revision rate (time frame: since the time of index operation until the initial revision or 2022/07/31). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534659, which also lists 3 linked publications.
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 16 Sep 2022.