Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

NCT01675037 | Terminated

• 2 other identifiers: 11226022011-A01077-34
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Hydrocephalus

Keywords

hypothalamic; pituitary,; endoscopic third ventriculostomy; hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy

  Complete hypothalamic-pituitary hormonal evaluation

  12 months

Study Arms (1)

obstructive

obstructive hydrocephalus in children and adults with biological evaluation

Other: Biological evaluation

Interventions

Biological evaluation OTHER

Complete hypothalamic-pituitary hormonal evaluation

obstructive

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• all patients over 6 months old with obstructive hydrocephalus who are referred for planned endoscopic third ventriculocisternostomy

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Univesity Hospital Toulouse

Toulouse, 31000, France

Location

Biospecimen

Retention: NONE RETAINED

Whole blood, and urine

MeSH Terms

Conditions

Hydrocephalus; Pituitary Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Endocrine System Diseases

Study Officials

• Franck-Emmanuel Roux, MD,PHD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 29, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)