<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/NCT04490668</url>
  </required_header>
  <id_info>
    <org_study_id>RJ-GC-Postop-complication 3</org_study_id>
    <nct_id>NCT04490668</nct_id>
  </id_info>
  <brief_title>Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery</brief_title>
  <official_title>Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      We investigate whether the intravenously administered human albumin is beneficial to prevent&#xD;
      anastomotic leakage after gastric cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical&#xD;
      postoperative complication. Anastomotic leakage severely compromises the recovery after&#xD;
      surgery. It increases the overall burden of patients and hospital resources. Postoperative&#xD;
      mortality is higher in patients with anastomotic leakage.&#xD;
&#xD;
      Human albumin is routinely administered after surgery with a unproven hypothesis that the&#xD;
      human albumin is beneficial to prevent anastomotic leakage. We investigate whether the&#xD;
      intravenously administered human albumin is beneficial to prevent anastomotic leakage after&#xD;
      gastric cancer surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the rate of anastomotic leakage</measure>
    <time_frame>Up to one months after the discharge of last patient</time_frame>
    <description>The rate of anastomotic leakage were compared among both groups</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1049</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Anastomotic Leak</condition>
  <arm_group>
    <arm_group_label>Human albumin support</arm_group_label>
    <description>Patients who received intravenous human albumin after gastric cancer surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No human albumin support</arm_group_label>
    <description>Patients who did not receive intravenous human albumin after gastric cancer surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human albumin</intervention_name>
    <description>Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.</description>
    <arm_group_label>Human albumin support</arm_group_label>
    <arm_group_label>No human albumin support</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with gastric cancer who underwent gastrectomy with adequate lymph node dissection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed gastric cancer&#xD;
&#xD;
          -  Patients who underwent radical gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who did not undergo gastrectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Birendra K Sah, PH D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chen Li, PH D</last_name>
    <role>Study Director</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhenggang Zhu, PH D</last_name>
    <role>Study Chair</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>BIRENDRA KUMAR SAH</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>Anastomotic leakage</keyword>
  <keyword>Human albumin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT04490668
org study id: RJ-GC-Postop-complication 3
nct id: NCT04490668
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We investigate whether the intravenously administered human albumin is beneficial to prevent
      anastomotic leakage after gastric cancer surgery.
Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical
      postoperative complication. Anastomotic leakage severely compromises the recovery after
      surgery. It increases the overall burden of patients and hospital resources. Postoperative
      mortality is higher in patients with anastomotic leakage.

      Human albumin is routinely administered after surgery with a unproven hypothesis that the
      human albumin is beneficial to prevent anastomotic leakage. We investigate whether the
      intravenously administered human albumin is beneficial to prevent anastomotic leakage after
      gastric cancer surgery.
observational model: Case-Control
time perspective: Retrospective
measure: Comparison of the rate of anastomotic leakage
time frame: Up to one months after the discharge of last patient
description: The rate of anastomotic leakage were compared among both groups
arm group label: Human albumin support
description: Patients who received intravenous human albumin after gastric cancer surgery
arm group label: No human albumin support
description: Patients who did not receive intravenous human albumin after gastric cancer surgery
intervention type: Biological
intervention name: Human albumin
description: Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.
arm group label: Human albumin support
arm group label: No human albumin support
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Birendra K Sah, PH D
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Chen Li, PH D
role: Study Director
affiliation: Ruijin Hospital
last name: Zhenggang Zhu, PH D
role: Study Chair
affiliation: Ruijin Hospital
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: BIRENDRA KUMAR SAH
investigator title: Principal investigator
mesh term: Stomach Neoplasms
mesh term: Anastomotic Leak
sharing ipd: No