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/NCT06031402</url>
    </required_header>
    <id_info>
      <org_study_id>XHNKKY-ENDO-AVB</org_study_id>
      <nct_id>NCT06031402</nct_id>
    </id_info>
    <brief_title>Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding</brief_title>
    <official_title>Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>General Hospital of Shenyang Military Region</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>General Hospital of Shenyang Military Region</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>
        Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal&#xD;
        bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis.&#xD;
        However, the optimal timing of endoscopy remains controversial, primarily because the&#xD;
        currently available evidence is of poor quality, and the definition of early endoscopy is&#xD;
        also very heterogeneous among studies. Herein, a multicenter randomized controlled trial&#xD;
        (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic&#xD;
        patients with AVB.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from&#xD;
        AVB will be enrolled. They will be stratified according to the severity of liver function and&#xD;
        hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12&#xD;
        hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups&#xD;
        within each stratum. The primary outcomes include the rates of 5-day failure to control&#xD;
        bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week&#xD;
        mortality and incidence of adverse events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 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>
      <intervention_model_description>Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The failure to control bleeding after admissions</measure>
      <time_frame>within 5 days admission</time_frame>
      <description>Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-week rebleeding</measure>
      <time_frame>6-week</time_frame>
      <description>Rebleeding is defined as new onset of hematemesis or melena after successful treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>6-week all-cause mortality</measure>
      <time_frame>6-week</time_frame>
      <description>Death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>up to 6 weeks</time_frame>
      <description>Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia during this trial.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">368</enrollment>
    <condition>Acute Upper Gastrointestinal Bleeding</condition>
    <condition>Acute Variceal Bleeding</condition>
    <arm_group>
      <arm_group_label>Early endoscopy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention of endoscopy is within 12 hours after admission</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Delayed endoscopy group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intervention of endoscopy is within 12-24 hours after admission</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopy</intervention_name>
      <description>Endoscopy</description>
      <arm_group_label>Delayed endoscopy group</arm_group_label>
      <arm_group_label>Early endoscopy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patients with AUGIB which is highly suspected to be caused by gastroesophageal&#xD;
               variceal rupture;&#xD;
  &#xD;
            2. patients with a diagnosis of liver cirrhosis based on imaging and pathology;&#xD;
  &#xD;
            3. patients and/or their relatives who sign informed consents;&#xD;
  &#xD;
            4. patients' age ≥18 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients who have undergone endoscopy at other hospitals before admissions;&#xD;
  &#xD;
            2. patients' hemodynamics are unstable after resuscitation;&#xD;
  &#xD;
            3. patients with severe cardiovascular or cerebrovascular diseases or renal injury;&#xD;
  &#xD;
            4. patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before&#xD;
               admissions, or are diagnosed with severe hematological diseases;&#xD;
  &#xD;
            5. patients with human immunodeficiency virus or other acquired or congenital immune&#xD;
               deficiency diseases;&#xD;
  &#xD;
            6. patients with mental illness;&#xD;
  &#xD;
            7. pregnancy.&#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>Xingshun Qi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>General Hospital of Shenyang Military Area</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mostafa Ibrahim, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Theodor Bilharz Research Institute</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yiling Li, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Hospital of China Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Bimin Li, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Nanchang University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xuefeng Luo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>West China Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xiaofeng Liu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The 960th Hospital of the Chinese People's Liberation Army</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Chunqing Zhang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Affiliated Provincial Hospital of Shandong First Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mingkai Chen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>People's Hospital of Wuhan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Derun Kong, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Anhui Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fernando G Romeiro, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Botucatu Medical School</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Andrea Mancuso, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nahum Méndez-Sánchez, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medica Sur Clinic and Foundation</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Enqiang Linghu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Medical Center of Chinese PLA General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xingshun Qi, MD</last_name>
      <phone>86-18909881019</phone>
      <email>xingshunqi@126.com</email>
    </overall_contact>
    <reference>
      <citation>Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282.</citation>
      <PMID>35048654</PMID>
    </reference>
    <reference>
      <citation>Peng Y, Qi X, Dai J, Li H, Guo X. Child-Pugh versus MELD score for predicting the in-hospital mortality of acute upper gastrointestinal bleeding in liver cirrhosis. Int J Clin Exp Med. 2015 Jan 15;8(1):751-7. eCollection 2015.</citation>
      <PMID>25785053</PMID>
    </reference>
    <reference>
      <citation>Peng Y, Qi X, Guo X. Child-Pugh Versus MELD Score for the Assessment of Prognosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis of Observational Studies. Medicine (Baltimore). 2016 Feb;95(8):e2877. doi: 10.1097/MD.0000000000002877.</citation>
      <PMID>26937922</PMID>
    </reference>
    <reference>
      <citation>Li Y, Li H, Zhu Q, Tsochatzis E, Wang R, Guo X, Qi X. Effect of acute upper gastrointestinal bleeding manifestations at admission on the in-hospital outcomes of liver cirrhosis: hematemesis versus melena without hematemesis. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1334-1341. doi: 10.1097/MEG.0000000000001524.</citation>
      <PMID>31524777</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>General Hospital of Shenyang Military Region</investigator_affiliation>
      <investigator_full_name>Xingshun Qi</investigator_full_name>
      <investigator_title>Director of Department of Gastroenterology</investigator_title>
    </responsible_party>
    <keyword>liver cirrhosis</keyword>
    <keyword>variceal bleeding</keyword>
    <keyword>gastrointestinal bleeding</keyword>
    <keyword>endoscopy</keyword>
    <keyword>survival</keyword>
    <keyword>randomized controlled trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06031402
  org study id: XHNKKY-ENDO-AVB
  nct id: NCT06031402
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal
        bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis.
        However, the optimal timing of endoscopy remains controversial, primarily because the
        currently available evidence is of poor quality, and the definition of early endoscopy is
        also very heterogeneous among studies. Herein, a multicenter randomized controlled trial
        (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic
        patients with AVB.
  A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from
        AVB will be enrolled. They will be stratified according to the severity of liver function and
        hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12
        hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups
        within each stratum. The primary outcomes include the rates of 5-day failure to control
        bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week
        mortality and incidence of adverse events.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The failure to control bleeding after admissions
  time frame: within 5 days admission
  description: Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.
  measure: 6-week rebleeding
  time frame: 6-week
  description: Rebleeding is defined as new onset of hematemesis or melena after successful treatment.
  measure: 6-week all-cause mortality
  time frame: 6-week
  description: Death
  measure: Adverse events
  time frame: up to 6 weeks
  description: Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia during this trial.
  arm group label: Early endoscopy group
  arm group type: Experimental
  description: Intervention of endoscopy is within 12 hours after admission
  arm group label: Delayed endoscopy group
  arm group type: Active Comparator
  description: Intervention of endoscopy is within 12-24 hours after admission
  intervention type: Procedure
  intervention name: Endoscopy
  description: Endoscopy
  arm group label: Delayed endoscopy group
  arm group label: Early endoscopy group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xingshun Qi, MD
  role: Principal Investigator
  affiliation: General Hospital of Shenyang Military Area
  last name: Mostafa Ibrahim, MD
  role: Principal Investigator
  affiliation: Theodor Bilharz Research Institute
  last name: Yiling Li, MD
  role: Principal Investigator
  affiliation: First Hospital of China Medical University
  last name: Bimin Li, MD
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Nanchang University
  last name: Xuefeng Luo, MD
  role: Principal Investigator
  affiliation: West China Hospital
  last name: Xiaofeng Liu, MD
  role: Principal Investigator
  affiliation: The 960th Hospital of the Chinese People's Liberation Army
  last name: Chunqing Zhang, MD
  role: Principal Investigator
  affiliation: Affiliated Provincial Hospital of Shandong First Medical University
  last name: Mingkai Chen, MD
  role: Principal Investigator
  affiliation: People's Hospital of Wuhan University
  last name: Derun Kong, MD
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Anhui Medical University
  last name: Fernando G Romeiro, MD
  role: Principal Investigator
  affiliation: Botucatu Medical School
  last name: Andrea Mancuso, MD
  role: Principal Investigator
  affiliation: Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
  last name: Nahum Méndez-Sánchez, MD
  role: Principal Investigator
  affiliation: Medica Sur Clinic and Foundation
  last name: Enqiang Linghu, MD
  role: Principal Investigator
  affiliation: The First Medical Center of Chinese PLA General Hospital
  last name: Xingshun Qi, MD
  phone: 86-18909881019
  email: xingshunqi@126.com
  citation: Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282.
  PMID: 35048654
  citation: Peng Y, Qi X, Dai J, Li H, Guo X. Child-Pugh versus MELD score for predicting the in-hospital mortality of acute upper gastrointestinal bleeding in liver cirrhosis. Int J Clin Exp Med. 2015 Jan 15;8(1):751-7. eCollection 2015.
  PMID: 25785053
  citation: Peng Y, Qi X, Guo X. Child-Pugh Versus MELD Score for the Assessment of Prognosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis of Observational Studies. Medicine (Baltimore). 2016 Feb;95(8):e2877. doi: 10.1097/MD.0000000000002877.
  PMID: 26937922
  citation: Li Y, Li H, Zhu Q, Tsochatzis E, Wang R, Guo X, Qi X. Effect of acute upper gastrointestinal bleeding manifestations at admission on the in-hospital outcomes of liver cirrhosis: hematemesis versus melena without hematemesis. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1334-1341. doi: 10.1097/MEG.0000000000001524.
  PMID: 31524777
  responsible party type: Principal Investigator
  investigator affiliation: General Hospital of Shenyang Military Region
  investigator full name: Xingshun Qi
  investigator title: Director of Department of Gastroenterology
  mesh term: Gastrointestinal Hemorrhage
  mesh term: Hemorrhage
  sharing ipd: No