<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675037</url>
  </required_header>
  <id_info>
    <org_study_id>1122602</org_study_id>
    <secondary_id>2011-A01077-34</secondary_id>
    <nct_id>NCT01675037</nct_id>
  </id_info>
  <brief_title>Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy</brief_title>
  <official_title>Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment&#xD;
      of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor&#xD;
      which is part of the hypothalamic-pituitary neuronal network is the key of this surgical&#xD;
      procedure.&#xD;
&#xD;
      Purpose: There are no prospective data available about the endocrine effects after ETV in&#xD;
      children and adults. The principal aim of this prospective study is to evaluate the&#xD;
      variability of hypothalamic-pituitary hormones and clinical effects in children and adults&#xD;
      after ETV in order to plan a multicentric study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment&#xD;
      of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor&#xD;
      which is part of the hypothalamic-pituitary neuronal network is the key of this surgical&#xD;
      procedure. Single patients with endocrine or electrolyte abnormalities after ETV have been&#xD;
      reported in children or adults. So far there are no prospective data available about the&#xD;
      endocrine effects after ETV.&#xD;
&#xD;
      Materials and methods 40 patients (10 children, 30 adults) with obstructive hydrocephalus and&#xD;
      inclusion criteria will undergo ETV in our neurosurgical department. Complete&#xD;
      hypothalamic-pituitary hormonal evaluation will be done, in children and adults, before the&#xD;
      procedure and at 3 and 12 month after ETV. At 3 month, a brain MRI, with&#xD;
      hypothalamic-pituitary specifics sequences, will be performed and compared to the&#xD;
      preoperative one. Follow up will be at 3 and 12 month after ETV.&#xD;
&#xD;
      Interventions: ETV is performed under general anesthesia with a rigid endoscope. Perforation&#xD;
      is made just behind the clivus, halfway between the infundibulum and the mammillary bodies in&#xD;
      the midline using a monopolar electrode, followed by dilatation with an inflated balloon&#xD;
      catheter. In our department, this procedure is performed only by 2 senior surgeons.&#xD;
&#xD;
      Number of subjects: 40 patients: 10 children, 30 adults. Statistical analysis: stratified&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment failure&#xD;
  </why_stopped>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy</measure>
    <time_frame>12 months</time_frame>
    <description>Complete hypothalamic-pituitary hormonal evaluation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Obstructive Hydrocephalus</condition>
  <arm_group>
    <arm_group_label>obstructive</arm_group_label>
    <description>obstructive hydrocephalus in children and adults with biological evaluation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biological evaluation</intervention_name>
    <description>Complete hypothalamic-pituitary hormonal evaluation</description>
    <arm_group_label>obstructive</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, and urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients over 6 months-old with obstructive hydrocephalus who are referred for planned&#xD;
        endoscopic third ventriculocisternostomy to department of neurosurgery in University&#xD;
        Hospital of Toulouse, France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients over 6 months old with obstructive hydrocephalus who are referred for&#xD;
             planned endoscopic third ventriculocisternostomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MRI contraindication, non obstructive hydrocephalus, life expectancy inferior of 3&#xD;
             months, ETV in emergency, hydrocephalus aetiology interaction with&#xD;
             hypothalamic-pituitary hormones, hydrocephalus already treated, basilar artery&#xD;
             malformations, to be allergic to tetracosactide (synacthene) and to benserazide&#xD;
             (Levodopa).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franck-Emmanuel Roux, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univesity Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>March 12, 2017</last_update_submitted>
  <last_update_submitted_qc>March 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypothalamic</keyword>
  <keyword>pituitary,</keyword>
  <keyword>endoscopic third ventriculostomy</keyword>
  <keyword>hydrocephalus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pituitary Diseases</mesh_term>
    <mesh_term>Hydrocephalus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675037
org study id: 1122602
secondary id: 2011-A01077-34
nct id: NCT01675037
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Variability of hypothalamic-pituitary hormones after endoscopic third ventriculostomy
time frame: 12 months
description: Complete hypothalamic-pituitary hormonal evaluation
arm group label: obstructive
description: obstructive hydrocephalus in children and adults with biological evaluation
intervention type: Other
intervention name: Biological evaluation
description: Complete hypothalamic-pituitary hormonal evaluation
arm group label: obstructive
Whole blood, and urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
last name: Franck-Emmanuel Roux, MD,PHD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Pituitary Diseases
mesh term: Hydrocephalus
sharing ipd: No