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Intracranial Hydatid Cyst

Primary Purpose

Intracranial Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cyst extirpation
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Neoplasm

Eligibility Criteria

4 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • intracranial hydatid cyst

Exclusion Criteria:

  • Arachnoid cysts
  • conservative treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    hydatid cyst

    Arm Description

    Outcomes

    Primary Outcome Measures

    number of patients who haven total removal of intracranial cyst
    degree of consciousness incomplete extirpation without removal without neurological deficit 0 space

    Secondary Outcome Measures

    Full Information

    First Posted
    June 27, 2020
    Last Updated
    June 30, 2020
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04454268
    Brief Title
    Intracranial Hydatid Cyst
    Official Title
    Intracranial Hydatid Cyst: Series of 8 Cases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    January 1, 2018 (Actual)
    Study Completion Date
    January 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Neoplasm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    hydatid cyst
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    cyst extirpation
    Intervention Description
    complete removal of the cyst without rupture
    Primary Outcome Measure Information:
    Title
    number of patients who haven total removal of intracranial cyst
    Description
    degree of consciousness incomplete extirpation without removal without neurological deficit 0 space
    Time Frame
    7 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: intracranial hydatid cyst Exclusion Criteria: Arachnoid cysts conservative treatment

    12. IPD Sharing Statement

    Learn more about this trial

    Intracranial Hydatid Cyst

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