<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/NCT03749005</url>
  </required_header>
  <id_info>
    <org_study_id>201801</org_study_id>
    <nct_id>NCT03749005</nct_id>
  </id_info>
  <brief_title>Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer</brief_title>
  <official_title>Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhujiang Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the multi-centre study is to evaluate correctly the impact of three dimensional&#xD;
      visualization on operation strategy and complications for Pancreatic Cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because of the complexity of Pancreatic Cancer, the limitations of 2D images of CT/MRI and&#xD;
      the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and&#xD;
      assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of&#xD;
      the multi-centre study is to evaluate correctly the impact of three-dimensional visualization&#xD;
      on operation strategy and complications for Pancreatic Cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact on operation strategy of three dimensional visualization technique</measure>
    <time_frame>30 days</time_frame>
    <description>Firstly, the operation strategies based on original CT or MRI image data will be made by the team, Secondly, the operation strategies based on three dimensional reconstruction models will be made by the team, then, actually surgical strategies will be recorded. The change of operation strategy will be assessed by comparing the strategy of the 2D model and 3D model. The change rate of operation strategy will be recorded and presented as percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact on complication of three dimensional visualization technique</measure>
    <time_frame>30 days</time_frame>
    <description>The early postoperative complication and mortality are defined as the event observed within 30 days after surgerypostoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complication (number) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year disease free survival rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pancreatic Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients with Pancreatic Cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.18 years≤ Age ≤70 years 2.Compling with the diagnosis criteria of Pancreatic Cancer.&#xD;
        3.Primary Pancreatic Cancer without metastasis. 4.The patients are volunteered for the&#xD;
        study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with mental illness.&#xD;
&#xD;
          2. Patients can't tolerate the operation owe to a variety of basic diseases (such as&#xD;
             severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system&#xD;
             diseases, etc.)&#xD;
&#xD;
          3. The patients refused to take part in the study.&#xD;
&#xD;
          4. There are other co-existed malignant tumors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Chihua Fang, M.D.;Ph.D</last_name>
    <phone>(+86)2062782568</phone>
    <email>s_mountain@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhujiang Hospital of The Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510282</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chihua Fang, MD</last_name>
      <phone>(+86)2062782568</phone>
      <email>s_mountain@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Three-dimensional Visualization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic 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/NCT03749005
org study id: 201801
nct id: NCT03749005
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the multi-centre study is to evaluate correctly the impact of three dimensional
      visualization on operation strategy and complications for Pancreatic Cancer.
Because of the complexity of Pancreatic Cancer, the limitations of 2D images of CT/MRI and
      the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and
      assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of
      the multi-centre study is to evaluate correctly the impact of three-dimensional visualization
      on operation strategy and complications for Pancreatic Cancer.
observational model: Cohort
time perspective: Retrospective
measure: Impact on operation strategy of three dimensional visualization technique
time frame: 30 days
description: Firstly, the operation strategies based on original CT or MRI image data will be made by the team, Secondly, the operation strategies based on three dimensional reconstruction models will be made by the team, then, actually surgical strategies will be recorded. The change of operation strategy will be assessed by comparing the strategy of the 2D model and 3D model. The change rate of operation strategy will be recorded and presented as percentage.
measure: Impact on complication of three dimensional visualization technique
time frame: 30 days
description: The early postoperative complication and mortality are defined as the event observed within 30 days after surgerypostoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complication (number) will be recorded.
measure: 1-year disease free survival rate
time frame: 12 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Chihua Fang, M.D.;Ph.D
phone: (+86)2062782568
email: s_mountain@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms