<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/NCT03828266</url>
  </required_header>
  <id_info>
    <org_study_id>2018YJZ56</org_study_id>
    <nct_id>NCT03828266</nct_id>
  </id_info>
  <brief_title>Prediction of Abdominal Complications After GastroEnterological Surgery</brief_title>
  <acronym>PACAGE</acronym>
  <official_title>Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking 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>
      The aim of this multi-centered study is to understand the epidemiology of infectious&#xD;
      complications after gastrointestinal surgery in China. In total, 17 centers from China will&#xD;
      prospectively register their patients undergo gastric or colorectal surgeries. Patient&#xD;
      demographic data, operation information, and postoperative data including the infectious&#xD;
      complications and the outcomes will be registered. We expect to include 2000 gastric and 2000&#xD;
      colorectal patients within one year and the study is expected to be finished in 2020.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participating hospital will log in on a website based e-CRF system. Researchers need to&#xD;
      register the patient information that three time-points: admission, after surgery, after&#xD;
      discharge.&#xD;
&#xD;
      The detailed registered information includes:&#xD;
&#xD;
      I. Basic and surgical information:&#xD;
&#xD;
      Age, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of&#xD;
      lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it&#xD;
      is emergency surgery, whether it is combined with organ resection, whether it is palliative&#xD;
      resection, whether combined with preoperative treatment, whether combined with preoperative&#xD;
      infection and intraoperative complications.&#xD;
&#xD;
      II. Postoperative information:&#xD;
&#xD;
      Primary lesion histological type, margin, pathological stage (pTNM); other complications,&#xD;
      postoperative death and discharge time, CRP, PCT, WBC levels.&#xD;
&#xD;
      III. Abdominal Infection information:&#xD;
&#xD;
      Abdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Abdominal Infection rate after gastrectomy.</measure>
    <time_frame>From surgery until discharge, up to 90 days.</time_frame>
    <description>Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdominal Infection rate after colorectal surgery.</measure>
    <time_frame>From surgery until discharge, up to 90 days.</time_frame>
    <description>Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Classification of Abdominal Infection after Surgery</measure>
    <time_frame>From surgery until discharge, up to 90 days.</time_frame>
    <description>Severity classification scored based on Clavien-Dindo score, it includes five different scales indicating different severity of the complication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis time of Abdominal Complication</measure>
    <time_frame>From surgery until discharge, up to 90 days.</time_frame>
    <description>1-3 days after surgery; 4-7 days after surgery; &gt;1wk after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome of Abdominal Infection Treatment</measure>
    <time_frame>From surgery until discharge, up to 90 days.</time_frame>
    <description>Cured before discharge, not cured before discharge, death.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Complication</condition>
  <condition>Anastomotic Leak</condition>
  <condition>Gastrointestinal Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Patients will undergo routine clinical practice. There is no additional intervention.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients undergo gastrointestinal (GI) surgery for GI tumor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned gastrointestinal surgery.&#xD;
&#xD;
          -  Inform consent received.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Endoscopic surgery.&#xD;
&#xD;
          -  Inform consent denied.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ziyu Li, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhouqiao Wu, MD PhD</last_name>
    <phone>0086-10-88196606</phone>
    <email>wuzhouqiao@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ziyu Li, M.D.</last_name>
      <email>ligregory369@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhouqiao Wu, M.D.</last_name>
      <email>wuzhouqiao@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ziyu Li, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhaohui Zheng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiamen University First Hospital</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jun You</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yong Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affilliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wu Song</last_name>
      <email>denisewei@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>South Hospital</name>
      <address>
        <city>Guanzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiang Yu</last_name>
      <email>balbc@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanchang University First Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhengrong Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jilin University Second Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiaming Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dalian Medical University First Hospital</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pin Liang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qinghai University Affiliated Hospital</name>
      <address>
        <city>Xining</city>
        <state>Qinghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Su Yan, MD</last_name>
      <email>yansu3598507@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changqing Jing</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qingdao University Affiliated Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhaojian Niu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hua Huang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hankun Hao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lu Zang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fenglin Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xi'an Jiao Tong University First Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Fan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hangzhou First Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Linghua Zhu</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Ziyu Li, MD</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Anastomotic Leak</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/NCT03828266
org study id: 2018YJZ56
nct id: NCT03828266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this multi-centered study is to understand the epidemiology of infectious
      complications after gastrointestinal surgery in China. In total, 17 centers from China will
      prospectively register their patients undergo gastric or colorectal surgeries. Patient
      demographic data, operation information, and postoperative data including the infectious
      complications and the outcomes will be registered. We expect to include 2000 gastric and 2000
      colorectal patients within one year and the study is expected to be finished in 2020.
All participating hospital will log in on a website based e-CRF system. Researchers need to
      register the patient information that three time-points: admission, after surgery, after
      discharge.

      The detailed registered information includes:

      I. Basic and surgical information:

      Age, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of
      lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it
      is emergency surgery, whether it is combined with organ resection, whether it is palliative
      resection, whether combined with preoperative treatment, whether combined with preoperative
      infection and intraoperative complications.

      II. Postoperative information:

      Primary lesion histological type, margin, pathological stage (pTNM); other complications,
      postoperative death and discharge time, CRP, PCT, WBC levels.

      III. Abdominal Infection information:

      Abdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome.
observational model: Cohort
time perspective: Prospective
measure: Abdominal Infection rate after gastrectomy.
time frame: From surgery until discharge, up to 90 days.
description: Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
measure: Abdominal Infection rate after colorectal surgery.
time frame: From surgery until discharge, up to 90 days.
description: Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
measure: Classification of Abdominal Infection after Surgery
time frame: From surgery until discharge, up to 90 days.
description: Severity classification scored based on Clavien-Dindo score, it includes five different scales indicating different severity of the complication.
measure: Diagnosis time of Abdominal Complication
time frame: From surgery until discharge, up to 90 days.
description: 1-3 days after surgery; 4-7 days after surgery; >1wk after surgery
measure: Outcome of Abdominal Infection Treatment
time frame: From surgery until discharge, up to 90 days.
description: Cured before discharge, not cured before discharge, death.
intervention type: Other
intervention name: No intervention
description: Patients will undergo routine clinical practice. There is no additional intervention.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ziyu Li, MD PhD
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Zhouqiao Wu, MD PhD
phone: 0086-10-88196606
email: wuzhouqiao@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
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status: Not yet recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
contact: 
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status: Not yet recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Ziyu Li, MD
investigator title: Prof. Dr.
mesh term: Gastrointestinal Neoplasms
mesh term: Anastomotic Leak
sharing ipd: No