Obstructive Hydrocephalus Clinical Trial
Official title:
Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy
Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment
of obstructive hydrocephalus in children and adults. Perforation of the third ventricle
floor which is part of the hypothalamic-pituitary neuronal network is the key of this
surgical procedure.
Purpose: There are no prospective data available about the endocrine effects after ETV in
children and adults. The principal aim of this prospective study is to evaluate the
variability of hypothalamic-pituitary hormones and clinical effects in children and adults
after ETV in order to plan a multicentric study.
Introduction Endoscopic third ventriculostomy (ETV) is a standard procedure for the
treatment of obstructive hydrocephalus in children and adults. Perforation of the third
ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of
this surgical procedure. Single patients with endocrine or electrolyte abnormalities after
ETV have been reported in children or adults. So far there are no prospective data available
about the endocrine effects after ETV.
Materials and methods 40 patients (10 children, 30 adults) with obstructive hydrocephalus
and inclusion criteria will undergo ETV in our neurosurgical department. Complete
hypothalamic-pituitary hormonal evaluation will be done, in children and adults, before the
procedure and at 3 and 12 month after ETV. At 3 month, a brain MRI, with
hypothalamic-pituitary specifics sequences, will be performed and compared to the
preoperative one. Follow up will be at 3 and 12 month after ETV.
Interventions: ETV is performed under general anesthesia with a rigid endoscope. Perforation
is made just behind the clivus, halfway between the infundibulum and the mammillary bodies
in the midline using a monopolar electrode, followed by dilatation with an inflated balloon
catheter. In our department, this procedure is performed only by 2 senior surgeons.
Number of subjects: 40 patients: 10 children, 30 adults. Statistical analysis: stratified
analysis.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Phase 2/Phase 3 | |
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N/A |