<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/NCT03749954</url>
  </required_header>
  <id_info>
    <org_study_id>CHESS1801</org_study_id>
    <nct_id>NCT03749954</nct_id>
  </id_info>
  <brief_title>Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Cirrhosis</brief_title>
  <official_title>Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Advanced Chronic Liver Disease (CHESS1801): A Prospective Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sir Run Run Shaw Hospital, Medical College, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Second Provincial General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fifth Affiliated Hospital of Zunyi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Baotou Medical College</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 is a serious complication of compensated advanced chronic liver&#xD;
      disease (cACLD). Primary prophylaxis to reduce the risk of variceal haemorrhage is&#xD;
      recommended if high-risk varices (HRV) are detected. We performed this study to compare the&#xD;
      accuracy, patients' satisfaction and safety of detection of HRV by detachable string&#xD;
      magnetically controlled capsule endoscopy (DS-MCCE) with esophagogastroduodenoscopy (EGD) as&#xD;
      the standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The presence of gastroesophageal varices (GEV) is a common and serious complication of&#xD;
      compensated advanced chronic liver disease (cACLD).1-3 GEV hemorrhage is associated with a&#xD;
      six week mortality rate of between 15% and 25%.2,3 In order to prevent variceal hemorrhage,&#xD;
      screening and surveillance aims to detect high-risk varices (HRV) and determine the need for&#xD;
      primary preventative therapy.2,3 Esophagogastroduodenoscopy (EGD) is therefore an important&#xD;
      part of the diagnostic work-up in patients with cACLD, serving as the gold standard to&#xD;
      diagnose HRV.2,3 However, EGD is invasive and poorly tolerated, with many patients needing&#xD;
      intravenous sedatives or general anesthesia. Although EGD with sedation relieves patients'&#xD;
      anxiety and discomfort and reduces the potential for physical injury during the procedure, it&#xD;
      incurs additional risks of cardiopulmonary adverse events.4 Consequently, patients may&#xD;
      decline a screening procedure if they are stable and asymptomatic.&#xD;
&#xD;
      Non-invasive methods for detection of cACLD are being explored.5-13 Although preliminary&#xD;
      research is encouraging, these techniques predict the presence, rather than confirm or assess&#xD;
      the size, of GEV. By contrast, capsule endoscopy is a non-invasive alternative which also&#xD;
      allows direct visualization of GEV.14 A number of well-conducted trials15-19 suggest that EGD&#xD;
      and capsule endoscopy may be equivalent in terms of accuracy in the identification and&#xD;
      grading of varices. However, concerns remain that the quality of examination may be adversely&#xD;
      affected by the uncontrolled and sometimes rapid transit of the capsule through the&#xD;
      esophagus.20 String capsule endoscopy was introduced to address this concern by providing&#xD;
      control of capsule movement as well as real-time visualization.21 However, this technique is&#xD;
      limited by the inability to detach the string from the capsule. Thus, observation of the&#xD;
      fundus, one of the predilection sites of varices, is impossible and retrieval of the capsule&#xD;
      from the esophagus causes discomfort.&#xD;
&#xD;
      Magnetically controlled capsule endoscopy (MCCE), a novel modality, was developed and&#xD;
      approved by the China Food and Drug Administration in 2013.22 Our previous studies initially&#xD;
      demonstrated that MCCE was comparable in accuracy to EGD for gastric examination.22,23&#xD;
      Furthermore, it has several strengths including non-invasiveness, no sedation requirement,&#xD;
      and easy operation.22,23 We have since combined an innovative detachable string system with&#xD;
      the MCCE (detachable string magnetically controlled capsule endoscopy (DS-MCCE)) and carried&#xD;
      out a pilot study showing that DS-MCCE was safe and feasible both in healthy volunteers and&#xD;
      patients with suspected esophageal disease.24 Moreover, successful detachment of the capsule&#xD;
      from the string avoids the discomfort of retrieving the entire capsule from the mouth and&#xD;
      allows subsequent investigation of the gastric cardia and fundus. To our knowledge, the&#xD;
      diagnostic accuracy of HRV, comfort and safety of DS-MCCE in patients with cACLD have not&#xD;
      been explored in a large-scale trial. This prospective, multicenter study aimed to assess the&#xD;
      accuracy, patient's satisfaction, and safety of DS-MCCE for detecting HRV in&#xD;
      well-characterized patients with cACLD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 9, 2018</start_date>
  <completion_date type="Anticipated">November 8, 2022</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</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 magnetically controlled capsule endoscopy for the risk of variceal bleeding</measure>
    <time_frame>1 day</time_frame>
    <description>Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of magnetically controlled capsule endoscopy for decompensation or death</measure>
    <time_frame>3 year</time_frame>
    <description>Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of other non-invasive methods for the risk of variceal bleeding</measure>
    <time_frame>1 day</time_frame>
    <description>Diagnostic accuracy of other non-invasive methods to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of other non-invasive methods for decompensation or death</measure>
    <time_frame>3 year</time_frame>
    <description>Diagnostic accuracy of other non-invasive methods to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Compensated 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 magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Detachable string magnetically controlled capsule endoscopy</intervention_name>
    <description>Esophagogastroduodenoscopy is performed 2 hours after the magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).</description>
    <arm_group_label>Overall eligible participants</arm_group_label>
    <other_name>Esophagogastroduodenoscopy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with compensated 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 cirrhosis based on liver biopsy or clinical findings;&#xD;
&#xD;
          -  compensated 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 capsule endoscopy;&#xD;
&#xD;
          -  contradictions for standard magnetic resonance imaging examination such as the&#xD;
             presence of surgical metallic devices;&#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>Xiaolong Qi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>LanZhou University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Fifth Medical Center of PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Second Provincial General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital, Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhujiang Hospital, Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fifth Affiliated Hospital of Zunyi Medical University</name>
      <address>
        <city>Zhuhai</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital affiliated to Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Baotou Medical College</name>
      <address>
        <city>Baotou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Third Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Trust</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>United Kingdom</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>Qi X, Li Z, Huang J, Zhu Y, Liu H, Zhou F, Liu C, Xiao C, Dong J, Zhao Y, Xu M, Xing S, Xu W, Yang C. Virtual portal pressure gradient from anatomic CT angiography. Gut. 2015 Jun;64(6):1004-5. doi: 10.1136/gutjnl-2014-308543. Epub 2014 Nov 14. No abstract available.</citation>
    <PMID>25398771</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>Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.</citation>
    <PMID>25590177</PMID>
  </reference>
  <reference>
    <citation>Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.</citation>
    <PMID>27211503</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>Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo SE, Tajiri H. Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope. Gastrointest Endosc. 2012 Feb;75(2):373-81. doi: 10.1016/j.gie.2011.09.030. Epub 2011 Dec 9.</citation>
    <PMID>22154417</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>LanZhou University</investigator_affiliation>
    <investigator_full_name>Xiaolong Qi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Magnetically controlled capsule endoscopy</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>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/NCT03749954
org study id: CHESS1801
nct id: NCT03749954
lead sponsor: 
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 is a serious complication of compensated advanced chronic liver
      disease (cACLD). Primary prophylaxis to reduce the risk of variceal haemorrhage is
      recommended if high-risk varices (HRV) are detected. We performed this study to compare the
      accuracy, patients' satisfaction and safety of detection of HRV by detachable string
      magnetically controlled capsule endoscopy (DS-MCCE) with esophagogastroduodenoscopy (EGD) as
      the standard.
The presence of gastroesophageal varices (GEV) is a common and serious complication of
      compensated advanced chronic liver disease (cACLD).1-3 GEV hemorrhage is associated with a
      six week mortality rate of between 15% and 25%.2,3 In order to prevent variceal hemorrhage,
      screening and surveillance aims to detect high-risk varices (HRV) and determine the need for
      primary preventative therapy.2,3 Esophagogastroduodenoscopy (EGD) is therefore an important
      part of the diagnostic work-up in patients with cACLD, serving as the gold standard to
      diagnose HRV.2,3 However, EGD is invasive and poorly tolerated, with many patients needing
      intravenous sedatives or general anesthesia. Although EGD with sedation relieves patients'
      anxiety and discomfort and reduces the potential for physical injury during the procedure, it
      incurs additional risks of cardiopulmonary adverse events.4 Consequently, patients may
      decline a screening procedure if they are stable and asymptomatic.

      Non-invasive methods for detection of cACLD are being explored.5-13 Although preliminary
      research is encouraging, these techniques predict the presence, rather than confirm or assess
      the size, of GEV. By contrast, capsule endoscopy is a non-invasive alternative which also
      allows direct visualization of GEV.14 A number of well-conducted trials15-19 suggest that EGD
      and capsule endoscopy may be equivalent in terms of accuracy in the identification and
      grading of varices. However, concerns remain that the quality of examination may be adversely
      affected by the uncontrolled and sometimes rapid transit of the capsule through the
      esophagus.20 String capsule endoscopy was introduced to address this concern by providing
      control of capsule movement as well as real-time visualization.21 However, this technique is
      limited by the inability to detach the string from the capsule. Thus, observation of the
      fundus, one of the predilection sites of varices, is impossible and retrieval of the capsule
      from the esophagus causes discomfort.

      Magnetically controlled capsule endoscopy (MCCE), a novel modality, was developed and
      approved by the China Food and Drug Administration in 2013.22 Our previous studies initially
      demonstrated that MCCE was comparable in accuracy to EGD for gastric examination.22,23
      Furthermore, it has several strengths including non-invasiveness, no sedation requirement,
      and easy operation.22,23 We have since combined an innovative detachable string system with
      the MCCE (detachable string magnetically controlled capsule endoscopy (DS-MCCE)) and carried
      out a pilot study showing that DS-MCCE was safe and feasible both in healthy volunteers and
      patients with suspected esophageal disease.24 Moreover, successful detachment of the capsule
      from the string avoids the discomfort of retrieving the entire capsule from the mouth and
      allows subsequent investigation of the gastric cardia and fundus. To our knowledge, the
      diagnostic accuracy of HRV, comfort and safety of DS-MCCE in patients with cACLD have not
      been explored in a large-scale trial. This prospective, multicenter study aimed to assess the
      accuracy, patient's satisfaction, and safety of DS-MCCE for detecting HRV in
      well-characterized patients with cACLD.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy of magnetically controlled capsule endoscopy for the risk of variceal bleeding
time frame: 1 day
description: Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard
measure: Diagnostic accuracy of magnetically controlled capsule endoscopy for decompensation or death
time frame: 3 year
description: Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up
measure: Diagnostic accuracy of other non-invasive methods for the risk of variceal bleeding
time frame: 1 day
description: Diagnostic accuracy of other non-invasive methods to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard
measure: Diagnostic accuracy of other non-invasive methods for decompensation or death
time frame: 3 year
description: Diagnostic accuracy of other non-invasive methods to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up
arm group label: Overall eligible participants
description: Eligible participants will receive standard esophagogastroduodenoscopy and magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
intervention type: Diagnostic Test
intervention name: Detachable string magnetically controlled capsule endoscopy
description: Esophagogastroduodenoscopy is performed 2 hours after the magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
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: Xiaolong Qi, M.D.
role: Principal Investigator
affiliation: LanZhou University
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
country: China
country: United Kingdom
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: Qi X, Li Z, Huang J, Zhu Y, Liu H, Zhou F, Liu C, Xiao C, Dong J, Zhao Y, Xu M, Xing S, Xu W, Yang C. Virtual portal pressure gradient from anatomic CT angiography. Gut. 2015 Jun;64(6):1004-5. doi: 10.1136/gutjnl-2014-308543. Epub 2014 Nov 14. No abstract available.
PMID: 25398771
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: Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
PMID: 25590177
citation: Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
PMID: 27211503
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: Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo SE, Tajiri H. Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope. Gastrointest Endosc. 2012 Feb;75(2):373-81. doi: 10.1016/j.gie.2011.09.030. Epub 2011 Dec 9.
PMID: 22154417
responsible party type: Principal Investigator
investigator affiliation: LanZhou University
investigator full name: Xiaolong Qi
investigator title: Professor
mesh term: Liver Cirrhosis
mesh term: Varicose Veins
mesh term: Hemorrhage
mesh term: Fibrosis
sharing ipd: Undecided
ipd description: Undecided