HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Официальное название

Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Обзор

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.

Подробное описание

The ESTHI Trial is a multi-center randomized controlled trial (RCT) comparing endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC) and shunt in infants with hydrocephalus. The study will leverage the infrastructure of the Hydrocephalus Clinical Research Network (HCRN), a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome is the primary concern of families and will, therefore, be the primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these two treatments. The results of the RCT will help families determine the optimal treatment of hydrocephalus for their child.

Вмешательства

• Процедура Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
  Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the
• Устройство Ventriculoperitoneal Shunt
  The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.

Первичные конечные точки

• Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score [Срок оценки: 12 months post randomized surgical intervention]

Вторичные конечные точки (2)

• Bayley Scale of Infant Development-IV (Bayley-IV) Language Scaled Score [Срок оценки: 12 months post randomized surgical intervention]
• Bayley Scale of Infant Development-IV (Bayley-IV) Motor Scaled Score [Срок оценки: 12 months post randomized surgical intervention]

Критерии участия

Критерии включения

• Corrected age <104 weeks and 0 days,

AND

• Child is ≥ 37 weeks post menstrual age,

AND

• Child must have symptomatic hydrocephalus, defined as:

Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, which approximates "moderate ventriculomegaly"), and at least one of the following:

• Head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures
• Upgaze paresis/palsy (sundowning)
• CSF leak
• Papilledema
• Tense pseudomeningocele or tense fluid along a track
• Vomiting or irritability, with no other attributable cause
• Bradycardias or apneas, with no other attributable cause
• Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves

AND

• No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)

Критерии исключения

• Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
• Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:

• Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX
• Closure of one or both foramina of Monro
• Thick floor of third ventricle (≥ 3mm)
• Narrow third ventricle (<5mm)
• Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
• Underlying condition with a high chance of mortality within 12 months; OR
• Hydrocephalus with loculated CSF compartments; OR
• Peritoneal cavity not suitable for distal shunt placement; OR
• Active CSF infection; OR
• Hydranencephaly; OR
• Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

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

США · 18 центров

• Children's of Alabama — Birmingham
• Phoenix Children's Hospital — Phoenix
• Children's Hospital of Los Angeles — Los Angeles
• Children's Hospital Colorado — Aurora
• Yale University — New Haven
• Wolfson Children's Hospital — Jacksonville
• Arnold Palmer Hospital for Children — Orlando
• Trustees of Indiana University — Indianapolis
• … и ещё 10 центров

Канада · 3 центра

• Alberta Children's Hospital — Calgary
• British Columbia Children's Hospital — Vancouver
• The Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT04177914 · HCRN 012 · 1U01NS107486-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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