<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/NCT03778775</url>
  </required_header>
  <id_info>
    <org_study_id>Pan-CHESS1801</org_study_id>
    <nct_id>NCT03778775</nct_id>
  </id_info>
  <brief_title>Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)</brief_title>
  <official_title>Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Patients With Compensated Cirrhosis (Pan-CHESS1801): An International Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tsinghua Changgeng Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xijing Hospital of Digestive Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Central Hospital of Lishui City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xingtai People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seventh Medical Center of PLA Army General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southern Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medistra Hospital, University of Indonesia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Osaka City University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</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>
      Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis.&#xD;
      Variceal bleeding is the most common lethal complication directly from cirrhotic portal&#xD;
      hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the&#xD;
      risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI&#xD;
      consensus, for those with high-risk varices (varies needing treatment), either non-selective&#xD;
      beta blockers or endoscopic band ligation is recommended for the prevention of the first&#xD;
      variceal bleeding. However, the invasiveness and uncomfortableness during the&#xD;
      esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice,&#xD;
      especially in compensated cirrhotic patients.&#xD;
&#xD;
      The important role of transient elastography for defining the presence of high-risk varices&#xD;
      was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver&#xD;
      stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than&#xD;
      150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models&#xD;
      (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score)&#xD;
      were shown to have potentials in distinguish the absence of high-risk gastroesophageal&#xD;
      varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or&#xD;
      hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out&#xD;
      high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in&#xD;
      Asia-Pacific population.&#xD;
&#xD;
      FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient&#xD;
      elastography based on a two-dimensional image-guided system to ensure the precise&#xD;
      orientation. In the present study, the investigators aim to conduct an international&#xD;
      prospective diagnostic trial with 16 sites to develop and validate the diagnostic performance&#xD;
      of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in&#xD;
      compensated cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis.&#xD;
      Variceal bleeding is the most common lethal complication directly from cirrhotic portal&#xD;
      hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the&#xD;
      risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI&#xD;
      consensus, for those with high-risk varices (varies needing treatment), either non-selective&#xD;
      beta blockers or endoscopic band ligation is recommended for the prevention of the first&#xD;
      variceal bleeding. However, the invasiveness and uncomfortableness during the&#xD;
      esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice,&#xD;
      especially in compensated cirrhotic patients.&#xD;
&#xD;
      The important role of transient elastography for defining the presence of high-risk varices&#xD;
      was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver&#xD;
      stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than&#xD;
      150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models&#xD;
      (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score)&#xD;
      were shown to have potentials in distinguish the absence of high-risk gastroesophageal&#xD;
      varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or&#xD;
      hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out&#xD;
      high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in&#xD;
      Asia-Pacific population.&#xD;
&#xD;
      FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient&#xD;
      elastography based on a two-dimensional image-guided system to ensure the precise&#xD;
      orientation. In the present study, the investigators aim to conduct an international&#xD;
      prospective diagnostic trial with 16 sites (Beijing Tsinghua Changgung Hospital, Lanzhou&#xD;
      University, The Fifth Medical Center of Chinese PLA General Hospital, Xijing Hospital of&#xD;
      Digestive Diseases Wuhan Union Hospital, Zhujiang Hospital, Second Affiliated Hospital of&#xD;
      Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital,&#xD;
      The Seventh Medical Center of Chinese PLA General Hospital Shandong Provincial Hospital,&#xD;
      Shunde Hospital, Southern Medical University Medistra Hospital; University of Indonesia,&#xD;
      Ankara University School of Medicine, Osaka City University, Chulalongkorn University) to&#xD;
      develop and validate the diagnostic performance of FibroTouch-based models for assessing risk&#xD;
      of gastroesophageal varices bleeding in compensated cirrhosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Anticipated">March 13, 2022</completion_date>
  <primary_completion_date type="Actual">June 13, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding</measure>
    <time_frame>1 day</time_frame>
    <description>Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation between FibroTouch-based models and HVPG</measure>
    <time_frame>1 day</time_frame>
    <description>The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension</measure>
    <time_frame>1 year</time_frame>
    <description>Diagnostic accuracy of FibroTouch-based models to determine the presence or absence of decompensated events (e.g. first variceal bleeding) within 1-year follow-up</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Compensated Liver Cirrhosis</condition>
  <condition>Gastroesophageal Varices Bleeding</condition>
  <arm_group>
    <arm_group_label>Overall eligible participants</arm_group_label>
    <description>Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Liver sitffness measurement</intervention_name>
    <description>Liver sitffness measurement is performed by FibroTouch, a new-generation of transient elastography with the tesing interval between liver sitffness measurement and esophagogastroduodenoscopy less than one week.</description>
    <arm_group_label>Overall eligible participants</arm_group_label>
    <other_name>Esophagogastroduodenoscopy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with compensated liver cirrhosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-75 years;&#xD;
&#xD;
          -  confirmed liver cirrhosis based on liver biopsy or clinical findings;&#xD;
&#xD;
          -  compensated liver cirrhosis;&#xD;
&#xD;
          -  scheduled to undergo esophagogastroduodenoscopy;&#xD;
&#xD;
          -  estimated survival time&gt; 24 months, and model for end-stage liver disease (MELD)&#xD;
             score&lt; 19;&#xD;
&#xD;
          -  with written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contradictions for esophagogastroduodenoscopy;&#xD;
&#xD;
          -  body mass index&gt; 35 kg/m2;&#xD;
&#xD;
          -  presence of decompensation events (e.g. ascites, variceal bleeding, hepatic&#xD;
             encephalopathy, etc.);&#xD;
&#xD;
          -  previous esophageal variceal banding legation or transjugular intrahepatic&#xD;
             portosystemic shunt;&#xD;
&#xD;
          -  current use of non-selective beta-blockers;&#xD;
&#xD;
          -  with portal vein thrombosis or hepatocellular carcinoma;&#xD;
&#xD;
          -  non-cirrhotic portal hypertension;&#xD;
&#xD;
          -  pregnancy or unknown pregnancy status.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiahong Dong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tsinghua Changgeng Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaolong Qi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaolong Qi, MD</last_name>
    <phone>18588602600</phone>
    <email>qixiaolong@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Seventh Medical Center of Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuai Wang, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Shuai Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yasong Li, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Fifth Medical Center of Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Guofeng Chen</last_name>
    </contact>
    <investigator>
      <last_name>Guofeng Chen, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dong Ji, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Tsinghua Changgung Hospital of Tsinghua University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102218</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jiahong Dong</last_name>
    </contact>
    <investigator>
      <last_name>Jiahong Dong, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lin Zhang, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiaorong Mao, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Xun Li, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiaorong Mao, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhujiang Hospital, Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hua Mao</last_name>
    </contact>
    <investigator>
      <last_name>Hua Mao, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shunde Hospital, Southern Medical University</name>
      <address>
        <city>Shunde</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Guoping Du, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Guoping Du, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xingtai People's Hospital</name>
      <address>
        <city>Xingtai</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dengxiang Liu, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Dengxiang Liu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Qingge Zhang, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital, China</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ling Yang, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Xiaohua Hou, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ling Yang, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chunqing Zhang, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Chunqing Zhang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jing Wang, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital of Digestive Diseases</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ying Han, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Ying Han, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xian</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zongfang Li, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Zongfang Li, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fanpu Ji, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Central Hospital of Lishui City</name>
      <address>
        <city>Lishui</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jiansong Ji, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Jiansong Ji, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zhongwei Zhao, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medistra Hospital, University of Indonesia</name>
      <address>
        <city>Jakarta</city>
        <country>Indonesia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cosmas Rinaldi A. Lesmana, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Cosmas Rinaldi A. Lesmana, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Osaka City University</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Norifumi Kawada, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Norifumi Kawada, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Medicine, Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sombat Treeprasertsuk, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Sombat Treeprasertsuk, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ankara University School of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Necati Örmeci, M.D.</last_name>
    </contact>
    <investigator>
      <last_name>Necati Örmeci, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
    <country>Indonesia</country>
    <country>Japan</country>
    <country>Thailand</country>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.</citation>
    <PMID>30215362</PMID>
  </reference>
  <reference>
    <citation>Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.</citation>
    <PMID>30268833</PMID>
  </reference>
  <reference>
    <citation>Wang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29.</citation>
    <PMID>25164003</PMID>
  </reference>
  <reference>
    <citation>de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.</citation>
    <PMID>26047908</PMID>
  </reference>
  <reference>
    <citation>Berzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, Garcia-Pagan JC, Pinzani M, Bosch J. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013 Jan;144(1):102-111.e1. doi: 10.1053/j.gastro.2012.10.001. Epub 2012 Oct 8.</citation>
    <PMID>23058320</PMID>
  </reference>
  <reference>
    <citation>Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.</citation>
    <PMID>27298379</PMID>
  </reference>
  <reference>
    <citation>Zhu Q, Wang W, Zhao J, Al-Asbahi AAM, Huang Y, Du F, Zhou J, Song Y, Xu K, Ye J, Yang L. Transient Elastography Identifies the Risk of Esophageal Varices and Bleeding in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Ultrasound Q. 2018 Sep;34(3):141-147. doi: 10.1097/RUQ.0000000000000373.</citation>
    <PMID>30020268</PMID>
  </reference>
  <reference>
    <citation>Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.</citation>
    <PMID>30457484</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Xiaolong Qi</investigator_full_name>
    <investigator_title>Director, Hepatic Hemodynamic Lab</investigator_title>
  </responsible_party>
  <keyword>Transient elastography</keyword>
  <keyword>Gastroesophageal varices bleeding</keyword>
  <keyword>Varices needing treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Esophageal and Gastric Varices</mesh_term>
    <mesh_term>Varicose Veins</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided.</ipd_description>
  </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/NCT03778775
org study id: Pan-CHESS1801
nct id: NCT03778775
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis.
      Variceal bleeding is the most common lethal complication directly from cirrhotic portal
      hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the
      risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI
      consensus, for those with high-risk varices (varies needing treatment), either non-selective
      beta blockers or endoscopic band ligation is recommended for the prevention of the first
      variceal bleeding. However, the invasiveness and uncomfortableness during the
      esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice,
      especially in compensated cirrhotic patients.

      The important role of transient elastography for defining the presence of high-risk varices
      was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver
      stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than
      150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models
      (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score)
      were shown to have potentials in distinguish the absence of high-risk gastroesophageal
      varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or
      hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out
      high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in
      Asia-Pacific population.

      FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient
      elastography based on a two-dimensional image-guided system to ensure the precise
      orientation. In the present study, the investigators aim to conduct an international
      prospective diagnostic trial with 16 sites to develop and validate the diagnostic performance
      of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in
      compensated cirrhosis.
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis.
      Variceal bleeding is the most common lethal complication directly from cirrhotic portal
      hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the
      risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI
      consensus, for those with high-risk varices (varies needing treatment), either non-selective
      beta blockers or endoscopic band ligation is recommended for the prevention of the first
      variceal bleeding. However, the invasiveness and uncomfortableness during the
      esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice,
      especially in compensated cirrhotic patients.

      The important role of transient elastography for defining the presence of high-risk varices
      was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver
      stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than
      150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models
      (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score)
      were shown to have potentials in distinguish the absence of high-risk gastroesophageal
      varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or
      hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out
      high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in
      Asia-Pacific population.

      FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient
      elastography based on a two-dimensional image-guided system to ensure the precise
      orientation. In the present study, the investigators aim to conduct an international
      prospective diagnostic trial with 16 sites (Beijing Tsinghua Changgung Hospital, Lanzhou
      University, The Fifth Medical Center of Chinese PLA General Hospital, Xijing Hospital of
      Digestive Diseases Wuhan Union Hospital, Zhujiang Hospital, Second Affiliated Hospital of
      Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital,
      The Seventh Medical Center of Chinese PLA General Hospital Shandong Provincial Hospital,
      Shunde Hospital, Southern Medical University Medistra Hospital; University of Indonesia,
      Ankara University School of Medicine, Osaka City University, Chulalongkorn University) to
      develop and validate the diagnostic performance of FibroTouch-based models for assessing risk
      of gastroesophageal varices bleeding in compensated cirrhosis.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding
time frame: 1 day
description: Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard
measure: The correlation between FibroTouch-based models and HVPG
time frame: 1 day
description: The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)
measure: Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension
time frame: 1 year
description: Diagnostic accuracy of FibroTouch-based models to determine the presence or absence of decompensated events (e.g. first variceal bleeding) within 1-year follow-up
arm group label: Overall eligible participants
description: Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch.
intervention type: Diagnostic Test
intervention name: Liver sitffness measurement
description: Liver sitffness measurement is performed by FibroTouch, a new-generation of transient elastography with the tesing interval between liver sitffness measurement and esophagogastroduodenoscopy less than one week.
arm group label: Overall eligible participants
other name: Esophagogastroduodenoscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jiahong Dong, MD
role: Principal Investigator
affiliation: Beijing Tsinghua Changgeng Hospital
last name: Xiaolong Qi, MD
role: Principal Investigator
affiliation: Nanfang Hospital, Southern Medical University
last name: Xiaolong Qi, MD
phone: 18588602600
email: qixiaolong@vip.163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: China
country: Indonesia
country: Japan
country: Thailand
country: Turkey
citation: Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
PMID: 30215362
citation: Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.
PMID: 30268833
citation: Wang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29.
PMID: 25164003
citation: de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
PMID: 26047908
citation: Berzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, Garcia-Pagan JC, Pinzani M, Bosch J. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013 Jan;144(1):102-111.e1. doi: 10.1053/j.gastro.2012.10.001. Epub 2012 Oct 8.
PMID: 23058320
citation: Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
PMID: 27298379
citation: Zhu Q, Wang W, Zhao J, Al-Asbahi AAM, Huang Y, Du F, Zhou J, Song Y, Xu K, Ye J, Yang L. Transient Elastography Identifies the Risk of Esophageal Varices and Bleeding in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Ultrasound Q. 2018 Sep;34(3):141-147. doi: 10.1097/RUQ.0000000000000373.
PMID: 30020268
citation: Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.
PMID: 30457484
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Xiaolong Qi
investigator title: Director, Hepatic Hemodynamic Lab
mesh term: Liver Cirrhosis
mesh term: Esophageal and Gastric Varices
mesh term: Varicose Veins
mesh term: Hemorrhage
mesh term: Fibrosis
sharing ipd: Undecided
ipd description: Undecided.