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Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

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ClinicalTrials.gov Identifier: NCT01675037
Recruitment Status : Terminated (Recruitment failure)
First Posted : August 29, 2012
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment
Obstructive Hydrocephalus Other: Biological evaluation

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.


Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy
Actual Study Start Date : July 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
obstructive
obstructive hydrocephalus in children and adults with biological evaluation
Other: Biological evaluation
Complete hypothalamic-pituitary hormonal evaluation




Primary Outcome Measures :
  1. Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy [ Time Frame: 12 months ]
    Complete hypothalamic-pituitary hormonal evaluation


Biospecimen Retention:   None Retained
Whole blood, and urine


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675037


Locations
France
Univesity Hospital Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Franck-Emmanuel Roux, MD,PHD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01675037     History of Changes
Other Study ID Numbers: 1122602
2011-A01077-34 ( Other Identifier: Afssaps )
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
hypothalamic
pituitary,
endoscopic third ventriculostomy
hydrocephalus

Additional relevant MeSH terms:
Pituitary Diseases
Hydrocephalus
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases