xml: <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/NCT06011980</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0407</org_study_id>
      <nct_id>NCT06011980</nct_id>
    </id_info>
    <brief_title>Life-2023-02 Esophagogastric Variceal Bleeding</brief_title>
    <official_title>Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
        Study on the efficacy of the growth inhibitors after endoscopic treatment of acute&#xD;
        esophagogastric variceal bleeding&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants with acute esophagogastric variceal bleeding in 5 days and under stable status&#xD;
        will be included in this study. All the patients will take CTP test to confirm the blood flow&#xD;
        status of the portal vein before endoscopic treatment. After that they will be randomly&#xD;
        divided into two groups: A. accept growth inhibitors after the endoscopic treatment for 5&#xD;
        days; B. no growth inhibitor will be applied after the treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 10, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 10, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>rebleeding rate after the endoscopic treatment in Group A at 1 month</measure>
      <time_frame>1 month after the endoscopic treatment</time_frame>
      <description>record the rebleeding incidence in this group A; (Rate A1= the number of rebleeding participants/the number of all the participants)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>rebleeding rate after the endoscopic treatment in Group A at 3 months</measure>
      <time_frame>3 months after the endoscopic treatment</time_frame>
      <description>record the rebleeding incidence in this group A; (Rate A2= the number of rebleeding participants/the number of all the participants)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>rebleeding rate after the endoscopic treatment in Group A at 6 months</measure>
      <time_frame>6 months after the endoscopic treatment</time_frame>
      <description>record the rebleeding incidence in this group A; (Rate A3= the number of rebleeding participants/the number of all the participants)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>rebleeding rate after the endoscopic treatment in Group B at 1 month</measure>
      <time_frame>1 month after the endoscopic treatment</time_frame>
      <description>record the rebleeding incidence in this group B; (Rate B1= the number of rebleeding participants/the number of all the participants)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>rebleeding rate after the endoscopic treatment in Group B at 3 months</measure>
      <time_frame>3 months after the endoscopic treatment</time_frame>
      <description>record the rebleeding incidence in this group B; (Rate B2= the number of rebleeding participants/the number of all the participants)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>rebleeding rate after the endoscopic treatment in Group B at 6 months</measure>
      <time_frame>6 months after the endoscopic treatment</time_frame>
      <description>record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Acute Esophageal Variceal Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will take growth inhibitors for 5 days after endoscopic treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this group will not take growth inhibitor treatment after endoscopic treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Growth Inhibitor</intervention_name>
      <description>growth inhibitors for 250-500μg/h, ivgtt. for 5 days</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  acute esophagogastric bleeding with hepatic cirhosis;&#xD;
  &#xD;
            -  stable status (no active bleeding)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  endoscopic test limitation;&#xD;
  &#xD;
            -  previous acute esophagogastric bleeding treatment history;&#xD;
  &#xD;
            -  ICU;&#xD;
  &#xD;
            -  pregnant;&#xD;
  &#xD;
            -  Immunity disabled;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>WEI WEI</last_name>
      <phone>15267175186</phone>
      <email>wwze@zju.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>2nd Affiliated Hospital, School of Medicine, Zhejiang University</name>
        <address>
          <city>Hanzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>WEI WEI</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Growth Inhibitors</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>on request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011980
  org study id: 2023-0407
  nct id: NCT06011980
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Study on the efficacy of the growth inhibitors after endoscopic treatment of acute
        esophagogastric variceal bleeding
  Participants with acute esophagogastric variceal bleeding in 5 days and under stable status
        will be included in this study. All the patients will take CTP test to confirm the blood flow
        status of the portal vein before endoscopic treatment. After that they will be randomly
        divided into two groups: A. accept growth inhibitors after the endoscopic treatment for 5
        days; B. no growth inhibitor will be applied after the treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: rebleeding rate after the endoscopic treatment in Group A at 1 month
  time frame: 1 month after the endoscopic treatment
  description: record the rebleeding incidence in this group A; (Rate A1= the number of rebleeding participants/the number of all the participants)
  measure: rebleeding rate after the endoscopic treatment in Group A at 3 months
  time frame: 3 months after the endoscopic treatment
  description: record the rebleeding incidence in this group A; (Rate A2= the number of rebleeding participants/the number of all the participants)
  measure: rebleeding rate after the endoscopic treatment in Group A at 6 months
  time frame: 6 months after the endoscopic treatment
  description: record the rebleeding incidence in this group A; (Rate A3= the number of rebleeding participants/the number of all the participants)
  measure: rebleeding rate after the endoscopic treatment in Group B at 1 month
  time frame: 1 month after the endoscopic treatment
  description: record the rebleeding incidence in this group B; (Rate B1= the number of rebleeding participants/the number of all the participants)
  measure: rebleeding rate after the endoscopic treatment in Group B at 3 months
  time frame: 3 months after the endoscopic treatment
  description: record the rebleeding incidence in this group B; (Rate B2= the number of rebleeding participants/the number of all the participants)
  measure: rebleeding rate after the endoscopic treatment in Group B at 6 months
  time frame: 6 months after the endoscopic treatment
  description: record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)
  arm group label: Group A
  arm group type: Experimental
  description: Participants in this group will take growth inhibitors for 5 days after endoscopic treatment.
  arm group label: Group B
  arm group type: No Intervention
  description: Participants in this group will not take growth inhibitor treatment after endoscopic treatment.
  intervention type: Drug
  intervention name: Growth Inhibitor
  description: growth inhibitors for 250-500μg/h, ivgtt. for 5 days
  arm group label: Group A
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: WEI WEI
  phone: 15267175186
  email: wwze@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Hemorrhage
  mesh term: Growth Inhibitors
  sharing ipd: Undecided
  ipd description: on request