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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy|
- Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy [ Time Frame: 12 mounth ] [ Designated as safety issue: No ]Complete hypothalamic-pituitary hormonal evaluation
Biospecimen Retention: None Retained
Whole blood, and urine
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
obstructive hydrocephalus in children and adults
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, halway 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675037
|Contact: Franck-Emmanuel Roux, MD; PHD||561772073 ext firstname.lastname@example.org|
|Univesity Hospital Toulouse||Recruiting|
|Toulouse, France, 31000|
|Contact: Delphine VERNET 0561777216 ext 33 email@example.com|
|Principal Investigator: Franck-Emmanuel Roux|
|Principal Investigator:||Franck-Emmanuel Roux, MD,PHD||University Hospital, Toulouse|