NCT07735936

Brief 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 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Aug 2029

Study Start

First participant enrolled

July 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 23, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

ETVCPChydrocephalus

Outcome Measures

Primary Outcomes (1)

  • 2. shunt-free survival

    The period that patients underwent ETV \& CPC stays without need for shunt

    2 years minimumly

Secondary Outcomes (2)

  • Change in health care burden of paediatric hydrocephalus

    2 years minimumly

  • Change in rate of hospital admissions

    2 years minimumly

Study Arms (1)

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.

Procedure: Combined endoscopic third ventriculostomy & coroid plexus cauterization

Interventions

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.

Combined ETV & CPC

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children below 18 years
  • Radiologically diagnosed obstructive hydrocephalus
  • Late onset aqueductal stenosis cases

You may not qualify if:

  • Communicating hydrocephalus.
  • Acute interventricular haemorrhage cases
  • Active infection cases
  • Multilocular hydrocephalus cases
  • Previous CSF diversion cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Ibraheem Ahmed Yosuf, Master degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2029

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations