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

NCT ID: NCT06488248

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2028-07-01

Brief Summary

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.

Detailed 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.

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic third ventriculostomy (ETV) group

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

Group Type: EXPERIMENTAL

Endoscopic third ventriculostomy (ETV)

Intervention Type: PROCEDURE

The procedure is performed using an endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent). The intervention is carried out under general anesthesia, with the procedure typically lasting around 60 minutes.

Ventriculoperitoneal shunt (VPS) group

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

Group Type: OTHER

Ventriculoperitoneal shunt (VPS)

Intervention Type: PROCEDURE

The procedure entails the insertion of a catheter into both the ventricular system and the peritoneal cavity, connected to a programmable valve that regulates cerebrospinal fluid flow. The choice of programmable valve (Codman Hakim or Codman Certas Programmable Valves, Integra, Plainsboro, USA; Strata valve, Medtronic, Minneapolis, USA; Sophysa, Orsay, France; Miethke proGAV, Aesculap, Tuttlingen, Germany) is at the surgeon's discretion. The preoperative valve setting is preset to a pressure level between 85 - 135 mmH2O. The VPS procedure is conducted under general anesthesia and typically lasts approximately 90-120 minutes.

Interventions

Endoscopic third ventriculostomy (ETV)

The procedure is performed using an endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent). The intervention is carried out under general anesthesia, with the procedure typically lasting around 60 minutes.

Intervention Type: PROCEDURE

Ventriculoperitoneal shunt (VPS)

The procedure entails the insertion of a catheter into both the ventricular system and the peritoneal cavity, connected to a programmable valve that regulates cerebrospinal fluid flow. The choice of programmable valve (Codman Hakim or Codman Certas Programmable Valves, Integra, Plainsboro, USA; Strata valve, Medtronic, Minneapolis, USA; Sophysa, Orsay, France; Miethke proGAV, Aesculap, Tuttlingen, Germany) is at the surgeon's discretion. The preoperative valve setting is preset to a pressure level between 85 - 135 mmH2O. The VPS procedure is conducted under general anesthesia and typically lasts approximately 90-120 minutes.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florian Marc Ebel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University Hospital of Basel

Locations

Department of Neurosurgery, University Hospital of Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Florian Marc Ebel, Dr. med.

Role: CONTACT

florianmarc.ebel@usb.ch

+41 61 32 84296

Raphael Guzman, Prof. Dr. med.

Role: CONTACT

raphael.guzman@usb.ch

+41 61 32 87522

Facility Contacts

Florian Marc Ebel, Dr. med.

Role: primary

florianmarc.ebel@usb.ch

+41 61 32 84296

Other Identifiers

2024-00845; ko23Soleman

Identifier Type: -

Identifier Source: org_study_id