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

Официальное название

Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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 lev

Первичные конечные точки

• idiopathic normal pressure hydrocephalus (iNPH) score [Срок оценки: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery]

Вторичные конечные точки (12)

• Level of consciousness (Glasgow Coma Scale) [Срок оценки: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery]
• Degree of disability and dependency (modified Rankin Scale) [Срок оценки: Up to 5 days, 2, 6, and 12 months after surgery]
• Cognitive function (Montreal Cognitive Assessment) [Срок оценки: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery]
• GaitRite walkway [Срок оценки: At 2 and 12 months after surgery]
• Timed-Up-and-Go Test [Срок оценки: At 2 and 12 months after surgery]
• Modified Clinical Test of Sensory Interaction on Balance [Срок оценки: At 2 and 12 months after surgery]
• Modified Balance Error Scoring System [Срок оценки: Before surgery (baseline), at 2 and 12 months after surgery]
• 5-times-sit-to-stand test [Срок оценки: At 2 and 12 months after surgery]
• Hand grip strength test [Срок оценки: At 2 and 12 months after surgery]
• Montreal Cognitive Assessment [Срок оценки: At 2 and 12 months after surgery]
• Test of Attentional Performance [Срок оценки: At 2 and 12 months after surgery]
• Trail Making Test [Срок оценки: At 2 and 12 months after surgery]

Критерии участия

Критерии включения

• >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

Критерии исключения

• ≤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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Department of Neurosurgery, University Hospital of Basel — Basel

Идентификаторы

NCT: NCT06488248 · 2024-00845; ko23Soleman

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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