HydrocephalusNCT06341946
Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt
A study testing Endoscopic third ventriculostomy in people with Hydrocephalus and Shunt Malfunction, run by Sohag University.
Trial summary
The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus, Shunt Malfunction
- What is being tested?
- Endoscopic third ventriculostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2024to Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • All patients with malfunctioning VP shunt will be included in this study.
Who cannot join
- Patients with contraindications for endoscopic procedure such as intracranial infection or bleeding disorders
- Previous unsuccessful attempts of endoscopic third ventriculostomy.
- Active infection or inflammation in the central nervous system.
- Recent history of intracranial hemorrhage.
- Medically unfit for surgery.
Trial locations and contacts
No sites are listed yet.
Roshdy Abdelaziz Elkahyat, MD, Professor of Neurosurgery contact
About this study
The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV).
Read the detailed description
Cerebrospinal fluid shunting remains the most common line of treatment for hydrocephalus. Endoscopic third ventriculostomy (ETV) is an alternative to cerebrospinal fluid (CSF) shunting that is potentially favorable due to the lack of implanted hardware. Most previous studies of ETV have focused on its role as an initial treatment for hydrocephalus and on comparing ETV with CSF shunting. However ,some patients who have previously been treated with a CSF shunt then developed malfunction are candidate for ETV.
The ETV Success Score (ETVSS) is the most widely used scale to estimate the likelihood of ETV success for a given patient .
Although the age of the patient is the most important component of the ETVSS, history of previous treatment with a shunt is also included in the model. According to the ETVSS, previous shunting reduces the likelihood of ETV success by approximately 10%.
There have been numerous previous studies of ETV in patients with a history of a CSF shunt (post shunt ETV), reporting success rates from 50% to 80% . Two review articles also covered this topic, one of which reported ETV success by meta-analysis in 68% of 519 pooled patients .
Most patients with shunt malfunction and or infection are treated with revision procedures, but ETV can be used as an alternative treatment in such cases .The role of endoscopic management of hydrocephalus in shunt malfunction was not investigated extensively so far.
There are several studies which have considered ETV as the main treatment of hydrocephalus inpatients with shunt failure.
Therefore, this is an attractive topic in neurosurgery especially in pediatric neurosurgery that can work and make a different kind of studies to explore the role of ETV for shunt failure.
The goal of the current study was to present our experience with endoscopic third ventriculostomy for management of shunt malfunction.
- Conditions
- Hydrocephalus, Shunt Malfunction
- Being tested
- Endoscopic third ventriculostomy
- Keywords
- endoscopic third ventriculostomy
- 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 ventriculostomyDevice
role of endoscopic third ventriculostomy in management of malfunctioning ventriculoperitoneal shunt
| Study group | Role | What they receive |
|---|---|---|
| endoscopic third ventriculostomy | Other | endoscopic third ventriculostomy in patients with malfunctioning ventriculoperitoneal shunt Receives: Device: Endoscopic third ventriculostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Coma Scale (GCS)
clinical symptoms improvement this Score has values between 3 and 15, 3 being the worst and 15 being the highest
Measured: base line
visual analogue scale( VAS )
clinical symptoms improvement this Score has values between 0 and 10, 0 being the best and 10 being the worst
Measured: base line
visual acuity
clinical symptoms improvement
Measured: base line
Secondary outcomes (1)
radiological CT brain and or MRI brain
CT brain and or MRI brain
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start5 Apr 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients with malfunctioning VP shunt will be included in this study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mahmoud Abdellah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341946
- Sponsor's protocol ID
- Soh-Med-24-02-05MD
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kulkarni AV, Drake JM, Kestle JR, Mallucci CL, Sgouros S, Constantini S; Canadian Pediatric Neurosurgery Study Group. Predicting who will benefit from endoscopic third ventriculostomy compared with shunt insertion in childhood hydrocephalus using the ETV Success Score. J Neurosurg Pediatr. 2010 Oct;6(4):310-5. doi: 10.3171/2010.8.PEDS103.
PubMed 20887100Kulkarni AV, Riva-Cambrin J, Browd SR. Use of the ETV Success Score to explain the variation in reported endoscopic third ventriculostomy success rates among published case series of childhood hydrocephalus. J Neurosurg Pediatr. 2011 Feb;7(2):143-6. doi: 10.3171/2010.11.PEDS10296.
PubMed 21284458Furtado LMF, da Costa Val Filho JA, Holliday JB, da Silva Costa J, de Matos MA, Nascimento VAM, Ramos Cavalcanti T. Endoscopic third ventriculostomy in patients with myelomeningocele after shunt failure. Childs Nerv Syst. 2020 Dec;36(12):3047-3052. doi: 10.1007/s00381-020-04596-5. Epub 2020 Apr 4.
PubMed 32248278Takeshige N, Uchikado H, Nakashima D, Negoto T, Nagase S, Yoshitomi M, Sakata K, Morioka M. Endoscopic third ventriculostomy for myelomeningocele-related hydrocephalus after shunt failure: Long-term outcome in a series of 8 patients. Clin Neurol Neurosurg. 2021 Feb;201:106406. doi: 10.1016/j.clineuro.2020.106406. Epub 2020 Dec 4.
PubMed 33341457Chhun V, Sacko O, Boetto S, Roux FE. Third Ventriculocisternostomy for Shunt Failure. World Neurosurg. 2015 Jun;83(6):970-5. doi: 10.1016/j.wneu.2015.01.058. Epub 2015 Mar 13.
PubMed 25772610Irrinki RNNS, Bawa M, Hegde S, Chhabra R, Gupta V, Gupta SK. Functional and Radiological Parameters to Assess Outcome of Endoscopic Third Ventriculostomy in Shunt Failure Patients. J Pediatr Neurosci. 2019 Apr-Jun;14(2):65-69. doi: 10.4103/jpn.JPN_31_19.
PubMed 31516622Talamonti G, Nichelatti M, Picano M, Marcati E, D'Aliberti G, Cenzato M. Endoscopic Third Ventriculostomy in Cases of Ventriculoperitoneal Shunt Malfunction: Does Shunt Duration Play a Role? World Neurosurg. 2019 Jul;127:e799-e808. doi: 10.1016/j.wneu.2019.03.268. Epub 2019 Apr 4.
PubMed 30954740Boschert J, Hellwig D, Krauss JK. Endoscopic third ventriculostomy for shunt dysfunction in occlusive hydrocephalus: long-term follow up and review. J Neurosurg. 2003 May;98(5):1032-9. doi: 10.3171/jns.2003.98.5.1032.
PubMed 12744363Bilginer B, Oguz KK, Akalan N. Endoscopic third ventriculostomy for malfunction in previously shunted infants. Childs Nerv Syst. 2009 Jun;25(6):683-8. doi: 10.1007/s00381-008-0779-1. Epub 2008 Dec 11.
PubMed 19082608
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt
- ClinicalTrials.gov ID
- NCT06341946
- Acronym / sponsor ID
- Soh-Med-24-02-05MD
- Conditions
- Hydrocephalus, Shunt Malfunction
- Keywords
- endoscopic third ventriculostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 2 Apr 2024 (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.
The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV).
Detailed description
Cerebrospinal fluid shunting remains the most common line of treatment for hydrocephalus. Endoscopic third ventriculostomy (ETV) is an alternative to cerebrospinal fluid (CSF) shunting that is potentially favorable due to the lack of implanted hardware. Most previous studies of ETV have focused on its role as an initial treatment for hydrocephalus and on comparing ETV with CSF shunting. However ,some patients who have previously been treated with a CSF shunt then developed malfunction are candidate for ETV.
The ETV Success Score (ETVSS) is the most widely used scale to estimate the likelihood of ETV success for a given patient .
Although the age of the patient is the most important component of the ETVSS, history of previous treatment with a shunt is also included in the model. According to the ETVSS, previous shunting reduces the likelihood of ETV success by approximately 10%.
There have been numerous previous studies of ETV in patients with a history of a CSF shunt (post shunt ETV), reporting success rates from 50% to 80% . Two review articles also covered this topic, one of which reported ETV success by meta-analysis in 68% of 519 pooled patients .
Most patients with shunt malfunction and or infection are treated with revision procedures, but ETV can be used as an alternative treatment in such cases .The role of endoscopic management of hydrocephalus in shunt malfunction was not investigated extensively so far.
There are several studies which have considered ETV as the main treatment of hydrocephalus inpatients with shunt failure.
Therefore, this is an attractive topic in neurosurgery especially in pediatric neurosurgery that can work and make a different kind of studies to explore the role of ETV for shunt failure.
The goal of the current study was to present our experience with endoscopic third ventriculostomy for management of shunt malfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients with malfunctioning VP shunt will be included in this study
| Arm | Type | Receives |
|---|---|---|
| endoscopic third ventriculostomy | Other | Device: Endoscopic third ventriculostomyendoscopic third ventriculostomy in patients with malfunctioning ventriculoperitoneal shunt |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- • All patients with malfunctioning VP shunt will be included in this study.
Key exclusion criteria (5 listed)
- Patients with contraindications for endoscopic procedure such as intracranial infection or bleeding disorders
- Previous unsuccessful attempts of endoscopic third ventriculostomy.
- Active infection or inflammation in the central nervous system.
- Recent history of intracranial hemorrhage.
- Medically unfit for surgery.
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 ventriculostomyrole of endoscopic third ventriculostomy in management of malfunctioning ventriculoperitoneal shunt | Device | endoscopic third ventriculostomy |
Primary outcome
Glasgow Coma Scale (GCS)
Time frame: base line
clinical symptoms improvement this Score has values between 3 and 15, 3 being the worst and 15 being the highest
visual analogue scale( VAS )
Time frame: base line
clinical symptoms improvement this Score has values between 0 and 10, 0 being the best and 10 being the worst
visual acuity
Time frame: base line
clinical symptoms improvement
1 secondary outcome
radiological CT brain and or MRI brain
Time frame: base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 20887100Kulkarni AV, Drake JM, Kestle JR, Mallucci CL, Sgouros S, Constantini S; Canadian Pediatric Neurosurgery Study Group. Predicting who will benefit from endoscopic third ventriculostomy compared with shunt insertion in childhood hydrocephalus using the ETV Success Score. J Neurosurg Pediatr. 2010 Oct;6(4):310-5. doi: 10.3171/2010.8.PEDS103.
- Background: PubMed 21284458Kulkarni AV, Riva-Cambrin J, Browd SR. Use of the ETV Success Score to explain the variation in reported endoscopic third ventriculostomy success rates among published case series of childhood hydrocephalus. J Neurosurg Pediatr. 2011 Feb;7(2):143-6. doi: 10.3171/2010.11.PEDS10296.
- Background: PubMed 32248278Furtado LMF, da Costa Val Filho JA, Holliday JB, da Silva Costa J, de Matos MA, Nascimento VAM, Ramos Cavalcanti T. Endoscopic third ventriculostomy in patients with myelomeningocele after shunt failure. Childs Nerv Syst. 2020 Dec;36(12):3047-3052. doi: 10.1007/s00381-020-04596-5. Epub 2020 Apr 4.
- Background: PubMed 33341457Takeshige N, Uchikado H, Nakashima D, Negoto T, Nagase S, Yoshitomi M, Sakata K, Morioka M. Endoscopic third ventriculostomy for myelomeningocele-related hydrocephalus after shunt failure: Long-term outcome in a series of 8 patients. Clin Neurol Neurosurg. 2021 Feb;201:106406. doi: 10.1016/j.clineuro.2020.106406. Epub 2020 Dec 4.
- Background: PubMed 25772610Chhun V, Sacko O, Boetto S, Roux FE. Third Ventriculocisternostomy for Shunt Failure. World Neurosurg. 2015 Jun;83(6):970-5. doi: 10.1016/j.wneu.2015.01.058. Epub 2015 Mar 13.
- Background: PubMed 31516622Irrinki RNNS, Bawa M, Hegde S, Chhabra R, Gupta V, Gupta SK. Functional and Radiological Parameters to Assess Outcome of Endoscopic Third Ventriculostomy in Shunt Failure Patients. J Pediatr Neurosci. 2019 Apr-Jun;14(2):65-69. doi: 10.4103/jpn.JPN_31_19.
- Background: PubMed 30954740Talamonti G, Nichelatti M, Picano M, Marcati E, D'Aliberti G, Cenzato M. Endoscopic Third Ventriculostomy in Cases of Ventriculoperitoneal Shunt Malfunction: Does Shunt Duration Play a Role? World Neurosurg. 2019 Jul;127:e799-e808. doi: 10.1016/j.wneu.2019.03.268. Epub 2019 Apr 4.
- Background: PubMed 12744363Boschert J, Hellwig D, Krauss JK. Endoscopic third ventriculostomy for shunt dysfunction in occlusive hydrocephalus: long-term follow up and review. J Neurosurg. 2003 May;98(5):1032-9. doi: 10.3171/jns.2003.98.5.1032.
- Background: PubMed 19082608Bilginer B, Oguz KK, Akalan N. Endoscopic third ventriculostomy for malfunction in previously shunted infants. Childs Nerv Syst. 2009 Jun;25(6):683-8. doi: 10.1007/s00381-008-0779-1. Epub 2008 Dec 11.
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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.
Roshdy Abdelaziz Elkahyat, MD, Professor of Neurosurgery contact
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic third ventriculostomy in people with Hydrocephalus and Shunt Malfunction, run by Sohag University.
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 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Mahmoud Abellah, M.B.B. Ch, M.Sc (01114514558 ext. +2, omr.hassan@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Coma Scale (GCS) (time frame: base line). The study lists 3 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 NCT06341946, which also lists 9 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 2 Apr 2024.