Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)

University Hospital Basel

Status: Enrolling

Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)

Treatments: Procedure: Ventriculoperitoneal shunt (VPS); Procedure: Endoscopic third ventriculostomy (ETV)

Study type: Interventional

Funder types: Other

Identifiers

NCT06488248

2024-00845 ko23Soleman;

Details and patient eligibility

About

The aim of this single-center, two-arm, open-labeled, randomized controlled clinical study is to compare two surgical interventions, endoscopic third ventriculostomy and ventriculoperitoneal shunt, in treating idiopathic normal pressure hydrocephalus in terms of clinical improvement.

Full description

Idiopathic normal pressure hydrocephalus (iNPH) primarily affects elderly individuals, with prevalence rates of approximately 1.4% among those over 65 years and 5.9% among those over 80 years old. It is characterized by fluid buildup in the brain with normal cerebrospinal fluid pressure and is unique among neurodegenerative disorders in its potential for successful treatment. Common symptoms include difficulty walking, urinary incontinence, and cognitive decline, which significantly impact quality of life.

The standard treatment involves inserting a ventriculoperitoneal shunt (VPS) to drain cerebrospinal fluid, achieving a 75% success rate in improving symptoms. However, VPS has a drawback: a high rate of revision surgery (approximately 18% during follow-up). An alternative treatment is endoscopic third ventriculostomy (ETV), which avoids placing foreign materials and thus eliminates risks associated with shunt malfunction and infections. ETV is an established neuroendoscopic procedure mainly used to treat non-communicating hydrocephalus, typically due to aqueduct stenosis.

This study aims to compare ETV and VPS for the treatment of iNPH to investigate whether ETV leads to fewer complications while achieving a comparable rate of postoperative symptom improvement.

Enrollment: 150 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >40 years of age
• Symptom duration ≥3 months, <24 months
• No antecedent head trauma, ICH, meningitis, or other cause of secondary hydrocephalus
• MUST show gait/balance disturbance, PLUS cognition impairment AND/OR urinary dysfunction.
• Ventricular enlargement (Evans Index > 0.3) not attributable to cerebral atrophy or congenital enlargement
• No macroscopic obstruction to cerebrospinal fluid (CSF) flow Spinal Tap-Test
• Opening pressure (on lateral decubitus): <24cmH2O
• Clinical improvement in at least one of the main symptoms after 40-50ml withdrawal of CSF

Exclusion criteria

• ≤40 years of age
• No informed consent
• Other neurologic, psychiatric or general medical condition which is sufficient to explain the presenting symptoms.
• Previous cranial neurosurgical interventions
• Other associated dementia syndromes
• Incapacity to walk
• Pregnancy and breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Endoscopic third ventriculostomy (ETV) group

Experimental group

Description:

The investigational group undergoes endoscopic third ventriculostomy (ETV) for the treatment of idiopathic normal pressure hydrocephalus (iNPH).

Treatment:

Procedure: Endoscopic third ventriculostomy (ETV)

Ventriculoperitoneal shunt (VPS) group

Other group

Description:

The control group undergoes ventriculoperitoneal shunt (VPS) implantation for the treatment of iNPH.

Treatment:

Procedure: Ventriculoperitoneal shunt (VPS)