Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

March 12, 2017 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • Univesity Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy
Time Frame: 12 months
Complete hypothalamic-pituitary hormonal evaluation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Franck-Emmanuel Roux, MD,PHD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1122602
  • 2011-A01077-34 (Other Identifier: Afssaps)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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