Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01675037
First received: August 27, 2012
Last updated: November 3, 2014
Last verified: November 2014
  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 Intervention
Obstructive Hydrocephalus
Other: Biological evaluation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
obstructive
obstructive hydrocephalus in children and adults with biological evaluation
Other: Biological evaluation
Complete hypothalamic-pituitary hormonal 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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675037

Contacts
Contact: Franck-Emmanuel Roux, MD; PHD 561772073 ext 33 franck_emmanuel.roux@yahoo.fr

Locations
France
Univesity Hospital Toulouse Recruiting
Toulouse, France, 31000
Contact: Delphine VERNET    0561777216 ext 33    vernet.d@chu-toulouse.fr   
Principal Investigator: Franck-Emmanuel Roux         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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: November 3, 2014
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
Intracranial Hypertension
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014