Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Obstructive Hydrocephalus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy |
Whole blood, and urine
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
obstructive
obstructive hydrocephalus in children and adults
|
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, 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.
Eligibility| Ages Eligible for Study: | 6 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
all patients over 6 month old with obstructive hydrocephalus who are referred for planned endoscopic third ventriculocisternostomy to our department of neurosurgery in University Hospital of Toulouse, France.
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 benzerazide (Levodopa).
Contacts and Locations| Contact: Franck-Emmanuel Roux, MD; PHD | 561772073 ext 33 | franck_emmanuel.roux@yahoo.fr |
| France | |
| Univesity Hospital Toulouse | Recruiting |
| Toulouse, France, 31000 | |
| Contact: Delphine VERNET 0561777216 ext 33 vernet.d@chu-toulouse.fr | |
| Principal Investigator: Franck-Emmanuel Roux | |
| Principal Investigator: | Franck-Emmanuel Roux, MD,PHD | University Hospital, Toulouse |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01675037 History of Changes |
| Other Study ID Numbers: | 1122602, 2011-A01077-34 |
| Study First Received: | August 27, 2012 |
| Last Updated: | August 27, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Toulouse:
|
hypothalamic pituitary, endoscopic third ventriculostomy hydrocephalus |
Additional relevant MeSH terms:
|
Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases Intracranial Hypertension |
ClinicalTrials.gov processed this record on May 21, 2013