Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial
University Hospital, Basel, Switzerland
150 participants
Jan 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- >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 Criteria7
- ≤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
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Interventions
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.
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.
Locations(1)
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NCT06488248