Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy
|ClinicalTrials.gov Identifier: NCT01675037|
Recruitment Status : Terminated (Recruitment failure)
First Posted : August 29, 2012
Last Update Posted : March 14, 2017
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.
|Condition or disease||Intervention/treatment|
|Obstructive Hydrocephalus||Other: Biological evaluation|
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.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy|
|Actual Study Start Date :||July 2012|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
obstructive hydrocephalus in children and adults with biological evaluation
Other: Biological evaluation
Complete hypothalamic-pituitary hormonal evaluation
- Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy [ Time Frame: 12 months ]Complete hypothalamic-pituitary hormonal evaluation
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675037
|Univesity Hospital Toulouse|
|Toulouse, France, 31000|
|Principal Investigator:||Franck-Emmanuel Roux, MD,PHD||University Hospital, Toulouse|