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/NCT05978752</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0437</org_study_id>
      <nct_id>NCT05978752</nct_id>
    </id_info>
    <brief_title>Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices</brief_title>
    <official_title>Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices Based on CT Hemodynamics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jinhua Hospital Affiliated to Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Lanxi People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Lishui Country People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shandong Provincial Hospital Affiliated to Shandong First Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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>
        The patients with GOV1 esophagogastric varices will be treated with gastric variceal tissue&#xD;
        gel injection, at the same time, the esophageal varices were treated with ligation,&#xD;
        sclerotherapy, or no treatment. A new method for the treatment of esophageal varices will be&#xD;
        proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter&#xD;
        hospital stays, and lower treatment costs, while further expanding HVPG testing to develop&#xD;
        the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type&#xD;
        esophageal and gastric varices.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cirrhotic portal hypertension can cause esophageal and gastric varices, and esophageal and&#xD;
        gastric varices bleeding (EGVB) were associated with portal vein pressure. At present, the&#xD;
        gold standard for detecting portal pressure in clinical practice is hepatic venous pressure&#xD;
        gradient (HVPG). For Sarin classification GOV1 of esophagogastric varices are from a single&#xD;
        origin, the left gastric vein. If the fundus varicose veins receive complete embolization&#xD;
        treatment, the esophageal variceal blood flow should be completely blocked, and such patients&#xD;
        do not need to perform esophageal surgery. However, this has not been reported in the&#xD;
        literature.&#xD;
  &#xD;
        Patients with esophageal and gastric varices identified by CT as GOV1 will be enrolled, all&#xD;
        of whom will receive HVPG detects. The patients were randomly divided into three groups. The&#xD;
        patients in group A will receive endoscopic gel embolization for gastric varices and&#xD;
        esophageal varices ligation treatment, group B patients will receive endoscopic gastric&#xD;
        variceal tissue glue embolization and esophageal variceal sclerotherapy treatment, the&#xD;
        patients in group C will receive endoscopic gelatinization of gastric fundus varices&#xD;
        (esophageal varices were not treated). Patients in the three groups were followed up with CTP&#xD;
        and gastroscopy 1 month, 3 months, and 6 months after the initial treatment, and additional&#xD;
        endoscopic treatment will be provided if necessary. If bleeding occurs again during this&#xD;
        period, timely treatment (medication, endoscopy, intervention or surgery) is required&#xD;
        according to the condition.&#xD;
  &#xD;
        A new method for the treatment of esophageal varices will be proposed to improve the&#xD;
        effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and&#xD;
        lower treatment costs, while further expanding HVPG testing to develop the best strategy for&#xD;
        secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and&#xD;
        gastric varices.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>
      <intervention_model_description>The patients with GOV1 esophagogastric varices were treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices was proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding the value of HVPG testing.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>hemostasis rate</measure>
      <time_frame>6 month</time_frame>
      <description>the percentage of hemostasis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative bleeding recurrence rate</measure>
      <time_frame>6 month</time_frame>
      <description>Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease &gt;10g/L</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">57</enrollment>
    <condition>Esophageal and Gastric Varices</condition>
    <arm_group>
      <arm_group_label>A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients will undergo endoscopic gel embolization of gastric fundus varices and esophageal varices ligation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients will undergo endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients will undergo endoscopic gelatinization of gastric varices (esophageal varices were not treated).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices</intervention_name>
      <description>For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with ligation.</description>
      <arm_group_label>A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices</intervention_name>
      <description>For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with sclerotherapy.</description>
      <arm_group_label>B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)</intervention_name>
      <description>For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated.</description>
      <arm_group_label>C</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  GOV1 esophageal and gastric varices identified by CT; more than 18 years old;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Complicated with liver cancer, severe cardiopulmonary insufficiency, stage III and&#xD;
               above hepatic encephalopathy, severe natural portal shunt formation, and previous&#xD;
               treatment of portal hypertensive bleeding (including endoscopic, interventional, and&#xD;
               surgical procedures).&#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>Wei Li, Master</last_name>
      <role>Study Director</role>
      <affiliation>2nd Affiliated Hospital, School of Medicine, Zhejiang University, China</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Liangjing Wang, Doctor</last_name>
      <role>Study Chair</role>
      <affiliation>2nd Affiliated Hospital, School of Medicine, Zhejiang University, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hongxia Li, Doctor</last_name>
      <phone>+8618252006898</phone>
      <email>lhx100918@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wei Wei, Master</last_name>
      <phone>+8615267175186</phone>
      <email>wwze@zju.edu.cn</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 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 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>GOV1 esophagogastric varices</keyword>
    <keyword>HVPG</keyword>
    <keyword>endoscopic treatment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal and Gastric Varices</mesh_term>
      <mesh_term>Varicose Veins</mesh_term>
    </condition_browse>
    <!-- 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/NCT05978752
  org study id: 2023-0437
  nct id: NCT05978752
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The patients with GOV1 esophagogastric varices will be treated with gastric variceal tissue
        gel injection, at the same time, the esophageal varices were treated with ligation,
        sclerotherapy, or no treatment. A new method for the treatment of esophageal varices will be
        proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter
        hospital stays, and lower treatment costs, while further expanding HVPG testing to develop
        the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type
        esophageal and gastric varices.
  Cirrhotic portal hypertension can cause esophageal and gastric varices, and esophageal and
        gastric varices bleeding (EGVB) were associated with portal vein pressure. At present, the
        gold standard for detecting portal pressure in clinical practice is hepatic venous pressure
        gradient (HVPG). For Sarin classification GOV1 of esophagogastric varices are from a single
        origin, the left gastric vein. If the fundus varicose veins receive complete embolization
        treatment, the esophageal variceal blood flow should be completely blocked, and such patients
        do not need to perform esophageal surgery. However, this has not been reported in the
        literature.
  
        Patients with esophageal and gastric varices identified by CT as GOV1 will be enrolled, all
        of whom will receive HVPG detects. The patients were randomly divided into three groups. The
        patients in group A will receive endoscopic gel embolization for gastric varices and
        esophageal varices ligation treatment, group B patients will receive endoscopic gastric
        variceal tissue glue embolization and esophageal variceal sclerotherapy treatment, the
        patients in group C will receive endoscopic gelatinization of gastric fundus varices
        (esophageal varices were not treated). Patients in the three groups were followed up with CTP
        and gastroscopy 1 month, 3 months, and 6 months after the initial treatment, and additional
        endoscopic treatment will be provided if necessary. If bleeding occurs again during this
        period, timely treatment (medication, endoscopy, intervention or surgery) is required
        according to the condition.
  
        A new method for the treatment of esophageal varices will be proposed to improve the
        effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and
        lower treatment costs, while further expanding HVPG testing to develop the best strategy for
        secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and
        gastric varices.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The patients with GOV1 esophagogastric varices were treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices was proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding the value of HVPG testing.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: hemostasis rate
  time frame: 6 month
  description: the percentage of hemostasis
  measure: Postoperative bleeding recurrence rate
  time frame: 6 month
  description: Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease >10g/L
  arm group label: A
  arm group type: Active Comparator
  description: The patients will undergo endoscopic gel embolization of gastric fundus varices and esophageal varices ligation.
  arm group label: B
  arm group type: Active Comparator
  description: The patients will undergo endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices.
  arm group label: C
  arm group type: Experimental
  description: The patients will undergo endoscopic gelatinization of gastric varices (esophageal varices were not treated).
  intervention type: Procedure
  intervention name: Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices
  description: For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with ligation.
  arm group label: A
  intervention type: Procedure
  intervention name: Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices
  description: For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with sclerotherapy.
  arm group label: B
  intervention type: Procedure
  intervention name: Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)
  description: For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated.
  arm group label: C
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wei Li, Master
  role: Study Director
  affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
  last name: Liangjing Wang, Doctor
  role: Study Chair
  affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
  last name: Hongxia Li, Doctor
  phone: +8618252006898
  email: lhx100918@163.com
  last name: Wei Wei, Master
  phone: +8615267175186
  email: wwze@zju.edu.cn
  responsible party type: Sponsor
  mesh term: Esophageal and Gastric Varices
  mesh term: Varicose Veins