<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/NCT04454268</url>
  </required_header>
  <id_info>
    <org_study_id>Intracranial Hydatid Cyst</org_study_id>
    <nct_id>NCT04454268</nct_id>
  </id_info>
  <brief_title>Intracranial Hydatid Cyst</brief_title>
  <official_title>Intracranial Hydatid Cyst: Series of 8 Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although&#xD;
      may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It&#xD;
      affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the&#xD;
      advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the&#xD;
      treatment of choice, resulting in most cases to a complete recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or&#xD;
      Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are&#xD;
      endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and&#xD;
      Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon,&#xD;
      Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less&#xD;
      commonly, Egypt)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">January 10, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of patients who haven total removal of intracranial cyst</measure>
    <time_frame>7 years</time_frame>
    <description>degree of consciousness incomplete extirpation without removal without neurological deficit 0 space</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Intracranial Neoplasm</condition>
  <arm_group>
    <arm_group_label>hydatid cyst</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cyst extirpation</intervention_name>
    <description>complete removal of the cyst without rupture</description>
    <arm_group_label>hydatid cyst</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  intracranial hydatid cyst&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Arachnoid cysts&#xD;
&#xD;
          -  conservative treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>ahmed salaheldin mohammed saro</investigator_full_name>
    <investigator_title>Assistant professor of neurosurgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Echinococcosis</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04454268
org study id: Intracranial Hydatid Cyst
nct id: NCT04454268
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although
      may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It
      affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the
      advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the
      treatment of choice, resulting in most cases to a complete recovery.
Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or
      Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are
      endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and
      Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon,
      Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less
      commonly, Egypt)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of patients who haven total removal of intracranial cyst
time frame: 7 years
description: degree of consciousness incomplete extirpation without removal without neurological deficit 0 space
arm group label: hydatid cyst
arm group type: Other
intervention type: Procedure
intervention name: cyst extirpation
description: complete removal of the cyst without rupture
arm group label: hydatid cyst
criteria: 
gender: All
minimum age: 4 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: ahmed salaheldin mohammed saro
investigator title: Assistant professor of neurosurgery
mesh term: Echinococcosis
mesh term: Brain Neoplasms