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Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01675037
Enrollment
11
Registered
2012-08-29
Start date
2012-07-31
Completion date
2015-07-31
Last updated
2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Hydrocephalus

Keywords

hypothalamic, pituitary,, endoscopic third ventriculostomy, hydrocephalus

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.

Interventions

OTHERBiological evaluation

Complete hypothalamic-pituitary hormonal evaluation

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy12 monthsComplete hypothalamic-pituitary hormonal evaluation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026