Paediatric HydrocephalusNCT07735936
Efficacy of Combined Endoscopic Third Ventriculostomy and Choroid Plexus Cauterization in Treatment of Hydrocephalus
A study testing Combined endoscopic third ventriculostomy & coroid plexus cauterization in people with Paediatric Hydrocephalus, run by Assiut University at 1 site in Egypt.
Trial summary
Hydrocephalus remains one of the most common conditions encountered in neurosurgery, traditionally managed by ventriculoperitoneal (VP) shunting. Despite its effectiveness, shunt dependency is associated with certain complications including infection, obstruction, and repeated revisions, leading to increased morbidity… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Paediatric Hydrocephalus
- What is being tested?
- Combined endoscopic third ventriculostomy & coroid plexus cauterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children below 18 years
- Radiologically diagnosed obstructive hydrocephalus
- Late onset aqueductal stenosis cases
Who cannot join
- Communicating hydrocephalus.
- Acute interventricular haemorrhage cases
- Active infection cases
- Multilocular hydrocephalus cases
- Previous CSF diversion cases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assuit University Hospital
Asyut, Asyut Governorate, 71515
Ibraheem Ahmed Yosuf, Master degree, +20 01118440865, Ebrahim.Ahmed@aun.edu.eg
About this study
Official title: Efficacy of Combined Endoscopic Third Ventriculostomy and Choroid Plexus Cauterization as Primary Treatment for Paediatric Hydrocephalus
Hydrocephalus remains one of the most common conditions encountered in neurosurgery, traditionally managed by ventriculoperitoneal (VP) shunting. Despite its effectiveness, shunt dependency is associated with certain complications including infection, obstruction, and repeated revisions, leading to increased morbidity and healthcare burden.
Over the last 70 years, cerebrospinal fluid (CSF) shunting and more recently endoscopic third ventriculostomy (ETV) have been the mainstays of hydrocephalus treatment. In recent years, choroid plexus cauterization (CPC) has re-emerged as an additional treatment strategy.
Read more
In combination with ETV, CPC increases the chances of successfully treating some cases with hydrocephalus, than ETV alone.
Endoscopic Third Ventriculostomy (ETV) has emerged as an alternative physiological treatment by creating a bypass for cerebrospinal fluid (CSF) flow. However, its success is limited in infants and in other varieties of hydrocephalus. The addition of Choroid Plexus Cauterization (CPC), which reduces CSF production, has been shown to improve outcomes when combined with ETV, particularly in younger patients.
The idea is based on the principle that ablation of the predominant source of CSF secretion within the brain, choroid plexus (CP), reduces CSF production. In addition, CPC may reduce CSF pulsatility, an effect which may be potentiated when combined with ETV, which might reduce intraventricular pulsations by serving as a pulsation absorber. These effects, in combination, may tip the balance in favour of CSF absorption and negate the need for shunting in a proportion of patients.
The combined ETV-CPC approach, popularized by Benjamin Warf, has demonstrated promising results in reducing shunt dependence, especially in resource-limited settings. However, variability in success rates persists due to differences in patient selection, etiology, and surgical expertise.
This study aims at evaluation of the efficacy of combined ETV-CPC as a primary treatment modality for hydrocephalus and to identify predictors of surgical success and failure, thereby optimizing patient selection and improving outcomes.
- Conditions
- Paediatric Hydrocephalus
- Being tested
- Combined endoscopic third ventriculostomy & coroid plexus cauterization
- Keywords
- ETV, CPC, hydrocephalus
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined endoscopic third ventriculostomy & coroid plexus cauterizationProcedure or surgery
Using ETV \& CPC in paediatric hydrocephalus will reduce Complications as CSF leak and Infection, Hospital stay, Evaluate time to failure, Compare outcomes across different hydrocephalus aetiologies and Medical care cost.
| Study group | Role | What they receive |
|---|---|---|
| Combined ETV & CPC | Experimental | 1. History: A complete medical history will be taken from the mother, including age when diagnosed, history of NICU admission, history suggestive of infection, other congenital anomalies or family history and any neurological symptoms.
2. Through physical examination:
* General examination including blood pressure, heart rate, respiratory rate, temprature.
* Neurological examination especially for GCS, anterior fontanelle, head circumference, cranial nerve affection and mental and physical growth.
* Visual assessment.
3. Investigations
* Radiology: CT brain and/or MRI brain with CSF flowmetry.
* Laboratory investigations like CBC, PT, PC,INR, renal enzymes and preoperative fitness.
4. Treatment modatities: Surgical strategy; ETV in combined with thermal cauterization of visible choroid plexus. Receives: Procedure: Combined endoscopic third ventriculostomy & coroid plexus cauterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
2. shunt-free survival
The period that patients underwent ETV \& CPC stays without need for shunt
Measured: 2 years minimumly
Secondary outcomes (2)
Change in health care burden of paediatric hydrocephalus
Measured: 2 years minimumly
Change in rate of hospital admissions
Measured: 2 years minimumly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric HydrocephalusStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebrahim Ahmed Yousof Abdelhakeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735936
- Sponsor's protocol ID
- ETV & CPC in hydrocephalus
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Endoscopic Third Ventriculostomy and Choroid Plexus Cauterization as Primary Treatment for Paediatric Hydrocephalus
- ClinicalTrials.gov ID
- NCT07735936
- Acronym / sponsor ID
- ETV & CPC in hydrocephalus
- Conditions
- Paediatric Hydrocephalus
- Keywords
- ETV, CPC, hydrocephalus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 30 Jul 2026 (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.
Hydrocephalus remains one of the most common conditions encountered in neurosurgery, traditionally managed by ventriculoperitoneal (VP) shunting. Despite its effectiveness, shunt dependency is associated with certain complications including infection, obstruction, and repeated revisions, leading to increased morbidity and healthcare burden.
Over the last 70 years, cerebrospinal fluid (CSF) shunting and more recently endoscopic third ventriculostomy (ETV) have been the mainstays of hydrocephalus treatment. In recent years, choroid plexus cauterization (CPC) has re-emerged as an additional treatment strategy.
In combination with ETV, CPC increases the chances of successfully treating some cases with hydrocephalus, than ETV alone.
Endoscopic Third Ventriculostomy (ETV) has emerged as an alternative physiological treatment by creating a bypass for cerebrospinal fluid (CSF) flow. However, its success is limited in infants and in other varieties of hydrocephalus. The addition of Choroid Plexus Cauterization (CPC), which reduces CSF production, has been shown to improve outcomes when combined with ETV, particularly in younger patients.
The idea is based on the principle that ablation of the predominant source of CSF secretion within the brain, choroid plexus (CP), reduces CSF production. In addition, CPC may reduce CSF pulsatility, an effect which may be potentiated when combined with ETV, which might reduce intraventricular pulsations by serving as a pulsation absorber. These effects, in combination, may tip the balance in favour of CSF absorption and negate the need for shunting in a proportion of patients.
The combined ETV-CPC approach, popularized by Benjamin Warf, has demonstrated promising results in reducing shunt dependence, especially in resource-limited settings. However, variability in success rates persists due to differences in patient selection, etiology, and surgical expertise.
This study aims at evaluation of the efficacy of combined ETV-CPC as a primary treatment modality for hydrocephalus and to identify predictors of surgical success and failure, thereby optimizing patient selection and improving outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined ETV & CPC | Experimental | Procedure: Combined endoscopic third ventriculostomy & coroid plexus cauterization1. History: A complete medical history will be taken from the mother, including age when diagnosed, history of NICU admission, history suggestive of infection, other congenital anomalies or family history and any neurological symptoms. 2. Through physical examination: * General examination including blood pressure, heart rate, respiratory rate, temprature. * Neurological examination especially for GCS, anterior fontanelle, head circumference, cranial nerve affection and mental and physical growth. * Visual assessment. 3. Investigations * Radiology: CT brain and/or MRI brain with CSF flowmetry. * Laboratory investigations like CBC, PT, PC,INR, renal enzymes and preoperative fitness. 4. Treatment modatities: Surgical strategy; ETV in combined with thermal cauterization of visible choroid plexus. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children below 18 years
- Radiologically diagnosed obstructive hydrocephalus
- Late onset aqueductal stenosis cases
Key exclusion criteria (5 listed)
- Communicating hydrocephalus.
- Acute interventricular haemorrhage cases
- Active infection cases
- Multilocular hydrocephalus cases
- Previous CSF diversion cases
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 |
|---|---|---|
| Combined endoscopic third ventriculostomy & coroid plexus cauterizationUsing ETV \& CPC in paediatric hydrocephalus will reduce Complications as CSF leak and Infection, Hospital stay, Evaluate time to failure, Compare outcomes across different hydrocephalus aetiologies and Medical care cost. | Procedure or surgery | Combined ETV & CPC |
Primary outcome
2. shunt-free survival
Time frame: 2 years minimumly
The period that patients underwent ETV \& CPC stays without need for shunt
2 secondary outcomes
Change in health care burden of paediatric hydrocephalus
Time frame: 2 years minimumly
Change in rate of hospital admissions
Time frame: 2 years minimumly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined endoscopic third ventriculostomy & coroid plexus cauterization in people with Paediatric Hydrocephalus, run by Assiut University at 1 site in Egypt.
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 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: opening soon, as of the sponsor's last update on 30 Jul 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibraheem Ahmed Yosuf, Master degree (+20 01118440865, Ebrahim.ahmed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2. shunt-free survival (time frame: 2 years minimumly). 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 30 Jul 2026.