Clinical trial NCT01675037: Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy
Official title: Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Hydrocephalus
Keywords: hypothalamic
pituitary,
endoscopic third ventriculostomy
hydrocephalus
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 6 months-old with obstructive hydrocephalus who are referred for planned endoscopic third ventriculocisternostomy to department of neurosurgery in University Hospital of Toulouse, France.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all patients over 6 months old with obstructive hydrocephalus who are referred for planned endoscopic third ventriculocisternostomy

Exclusion Criteria:

* MRI contraindication, non obstructive hydrocephalus, life expectancy inferior of 3 months, ETV in emergency, hydrocephalus aetiology interaction with hypothalamic-pituitary hormones, hydrocephalus already treated, basilar artery malformations, to be allergic to tetracosactide (synacthene) and to benserazide (Levodopa).

Primary outcomes:
measure: Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Univesity Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Franck-Emmanuel Roux, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: