<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/NCT03748563</url>
  </required_header>
  <id_info>
    <org_study_id>CENTERS</org_study_id>
    <nct_id>NCT03748563</nct_id>
  </id_info>
  <brief_title>Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrhosis</brief_title>
  <official_title>Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of Esophagogastric Varices in Patients With Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ruijin 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>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai East Hospital of Tongji University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yangpu District Central Hospital Affiliated to Tongji University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</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>The First Affiliated Hospital of Zhejiang Chinese Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Pudong New Area Gongli Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to&#xD;
      undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is&#xD;
      compared, and it will be performed within 48 hours after ds-MCE examination. The primary&#xD;
      outcome is the sensitivity and specificity of ds-MCE in identifying the presence of&#xD;
      esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference.&#xD;
      The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV,&#xD;
      red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The&#xD;
      incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD&#xD;
      procedures, patient satisfaction assessment and safety evaluation will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cirrhosis is the major cause of liver disease-related morbidity and mortality worldwide.&#xD;
      Portal hypertension (PH) is the hemodynamic abnormality in patients with cirrhosis, which is&#xD;
      associated with various pathological changes throughout the entire gastrointestinal tract,&#xD;
      manifesting as esophagogastric varices (EGV), portal hypertensive gastropathy (PHG), and&#xD;
      portal hypertensive enteropathy (PHE). Baveno consensus and other practice guidelines&#xD;
      recommended that patients with cirrhosis undergo endoscopic screening for EGV at the time of&#xD;
      diagnosis and undergo periodic surveillance endoscopy throughout the whole course of&#xD;
      cirrhosis.&#xD;
&#xD;
      Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and&#xD;
      follow-up of EGV in cirrhotic patients, allowing for direct mucosal visualization and&#xD;
      therapeutic intervention. EGD is however an invasive procedure and there is potential for&#xD;
      procedure-related complications, such as perforation and bleeding. Besides, conscious&#xD;
      sedation is always required, leading to increased cost, risk, and inconvenience for the&#xD;
      patients.These factors lead to a decrease of patient compliance as well as the effectiveness&#xD;
      of the screening program.&#xD;
&#xD;
      The capsule endoscopy (CE) system provides a noninvasive and relatively comfortable approach&#xD;
      to visualize the GI tract, and the development of esophageal capsule endoscopy (ECE) makes it&#xD;
      possible to capture clear images of esophagus without the need of sedation. However, the&#xD;
      accuracy of ECE is not currently sufficient to replace EGD for the detection and grading for&#xD;
      the esophageal varices. Besides, previous studies presented that the sensitivity of ECE for&#xD;
      detecting gastric varices (GVs) and PHG varies from 3% to 69%, which denoted ECE was far from&#xD;
      a suitable alternative for diagnosing gastric lesions.&#xD;
&#xD;
      To overcome these limitations, a new technique, so-called detachable string magnetically&#xD;
      maneuvered capsule endoscopy (ds-MCE) was developed. The ds-MCE system consists of two parts:&#xD;
      the magnetically maneuvered capsule endoscopy (MCE) system and a transparent latex sleeve&#xD;
      with a hollow string. One end of the hollow string is a transparent thin latex sleeve that&#xD;
      can be wrapped on the surface of the capsule, and the other end of the string is connected to&#xD;
      the syringe. The capsule, which is partially enclosed within the sleeve, can be actively&#xD;
      moved in the esophagus through the control of string. In this case, investigator can examine&#xD;
      the entire esophageal mucosa several times under real time views. The capsule then can be&#xD;
      detached from the string system through injecting air into the hollow string with the syringe&#xD;
      after completing the examination of esophagus. The magnetic capsule in the stomach can be&#xD;
      accurately controlled through multidimensional rotation and adaptive matching of an external&#xD;
      C-arm robot. Previous studies have demonstrated that the diagnostic accuracy of MCE for&#xD;
      detecting gastric focal lesions is comparable with that of conventional EGD. Two previously&#xD;
      studies of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely&#xD;
      viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life&#xD;
      of the ds-MCE enables complete examination of the small bowel, which enables to provide a&#xD;
      more comprehensive evaluation of gastrointestinal changes.&#xD;
&#xD;
      Considering all these backgrounds, in the current prospective study, the primary aim is to&#xD;
      assess the diagnostic performance of the ds-MCE in identifying the presence of EGV in&#xD;
      cirrhotic patients, using EGD as the reference standard. The diagnostic accuracy of ds-MCE in&#xD;
      detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV&#xD;
      and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel&#xD;
      under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction&#xD;
      assessment and safety evaluation will also be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2021</start_date>
  <completion_date type="Actual">March 6, 2023</completion_date>
  <primary_completion_date type="Actual">January 10, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Diagnostic accuracy study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV)</measure>
    <time_frame>2 weeks</time_frame>
    <description>the sensitivity and specificity of ds-MCE in identifying EGV in patients with cirrhosis, using the detection by EGD as the reference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in identifying the presence of esophageal varices (EV)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of EV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in identifying the red sign of EV</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in identifying the red sign of EV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in differentiating large esophageal varices</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of large EV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the optimal esophageal luminal circumference percentage threshold under ds-MCE for distinguishing large EV</measure>
    <time_frame>2 weeks</time_frame>
    <description>To investigate the optimal threshold of the proportion of ds-MCE esophageal luminal circumference occupied by the largest esophageal varix present in differentiating large EV from small or no EV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in differentiating high-risk esophageal varices</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in detection of high-risk EGV</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EGV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in detecting gastric varices (GV)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of GV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in detecting cardiofundal gastric varices</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of cardiofundal GV, using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy</measure>
    <time_frame>2 weeks</time_frame>
    <description>The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of portal hypertensive gastropathy (PHG), using the detection by EGD as the reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the incidence of portal hypertensive enteropathy (PHE) under ds-MCE</measure>
    <time_frame>2 weeks</time_frame>
    <description>Endoscopic findings of PHE include mucosal inflammatory-like abnormalities, vascular lesions and spontaneous bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the examination time of ds-MCE and EGD</measure>
    <time_frame>2 weeks</time_frame>
    <description>Examination time of ds-MCE include esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), small bowel transit time (SBTT), and total running time (TRT). Examination time of EGD is the time from the endoscope entering to exiting from the esophagus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction evaluation of the ds-MCE and EGD</measure>
    <time_frame>2 weeks</time_frame>
    <description>Patient satisfaction score of ds-MCE and EGD procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation</measure>
    <time_frame>2 weeks</time_frame>
    <description>All adverse events occurring during the study will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">607</enrollment>
  <condition>Liver Cirrhosis</condition>
  <condition>Portal Hypertension</condition>
  <condition>Esophageal Varices</condition>
  <condition>Gastric Varix</condition>
  <arm_group>
    <arm_group_label>ds-MCE and EGD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the enrolled participants will undergo the examination of detachable string magnetically maneuvered capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ds-MCE and EGD</intervention_name>
    <description>Procedure of ds-MCE:&#xD;
The ds-MCE system mainly consists of two parts: the NaviCam magnetically maneuvered capsule endoscopy system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. After completing the esophageal examination, the capsule could be detached from the string through injecting air into the hollow string with the syringe. Then, the examination of stomach under magnetic control and small bowel under the natural action of gastrointestinal peristalsis follows.&#xD;
Procedure of EGD:&#xD;
The esophagogastroduodenoscopy (EGD) will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session.</description>
    <arm_group_label>ds-MCE and EGD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gender is not limited.&#xD;
&#xD;
          2. Patients aged 18 years or older.&#xD;
&#xD;
          3. Both inpatients and outpatients.&#xD;
&#xD;
          4. Clinically evident or biopsy-proven liver cirrhosis.&#xD;
&#xD;
          5. Able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients aged less than 18 years.&#xD;
&#xD;
          2. Patients with Zenker's diverticulum.&#xD;
&#xD;
          3. Patients with active gastrointestinal bleeding.&#xD;
&#xD;
          4. Patients who have participated in or are participating in other clinical trials.&#xD;
&#xD;
          5. Pregnancy or suspected pregnancy.&#xD;
&#xD;
          6. Suspected or known intestinal stenosis or other known risk factors for capsule&#xD;
             retention.&#xD;
&#xD;
          7. Pacemaker or other implanted electromedical devices which could interfere with&#xD;
             magnetic resonance.&#xD;
&#xD;
          8. Patients with dysphagia.&#xD;
&#xD;
          9. Life-threatening conditions.&#xD;
&#xD;
         10. Patients plan to undergo magnetic resonance imaging examination before excretion of&#xD;
             the MCE.&#xD;
&#xD;
         11. Patients who refuse to give informed consent.&#xD;
&#xD;
         12. Patients with any condition that precludes compliance with the study.&#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>Zhuan Liao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhujiang Hospital,Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <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>
        <zip>519000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Jiao Tong University affiliated Sixth people's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <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>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Pudong New Area Gongli Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200135</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yangpu District Central Hospital Affiliated to Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang Chinese Medical University</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <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>North Italian Endoscopic Club for the Study and Treatment of Esophageal Varices. Prediction of the first variceal hemorrhage in patients with cirrhosis of the liver and esophageal varices. A prospective multicenter study. N Engl J Med. 1988 Oct 13;319(15):983-9. doi: 10.1056/NEJM198810133191505.</citation>
    <PMID>3262200</PMID>
  </reference>
  <reference>
    <citation>Spina GP, Arcidiacono R, Bosch J, Pagliaro L, Burroughs AK, Santambrogio R, Rossi A. Gastric endoscopic features in portal hypertension: final report of a consensus conference, Milan, Italy, September 19, 1992. J Hepatol. 1994 Sep;21(3):461-7. doi: 10.1016/s0168-8278(05)80329-0. No abstract available.</citation>
    <PMID>7836719</PMID>
  </reference>
  <reference>
    <citation>Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607.</citation>
    <PMID>1446890</PMID>
  </reference>
  <reference>
    <citation>Kodama M, Uto H, Numata M, Hori T, Murayama T, Sasaki F, Tsubouchi N, Ido A, Shimoda K, Tsubouchi H. Endoscopic characterization of the small bowel in patients with portal hypertension evaluated by double balloon endoscopy. J Gastroenterol. 2008;43(8):589-96. doi: 10.1007/s00535-008-2198-1. Epub 2008 Aug 17.</citation>
    <PMID>18709480</PMID>
  </reference>
  <reference>
    <citation>D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.</citation>
    <PMID>12939586</PMID>
  </reference>
  <reference>
    <citation>Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available. Erratum In: Hepatology. 2007 Dec;46(6):2052.</citation>
    <PMID>17879356</PMID>
  </reference>
  <reference>
    <citation>Lapalus MG, Dumortier J, Fumex F, Roman S, Lot M, Prost B, Mion F, Ponchon T. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endoscopy. 2006 Jan;38(1):36-41. doi: 10.1055/s-2006-924975.</citation>
    <PMID>16429353</PMID>
  </reference>
  <reference>
    <citation>Gralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting esophageal disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2. Endoscopy. 2008 Apr;40(4):275-9. doi: 10.1055/s-2007-995645.</citation>
    <PMID>18389444</PMID>
  </reference>
  <reference>
    <citation>de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227.</citation>
    <PMID>18435461</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Zhuan Liao</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Capsule Endoscopy</keyword>
  <keyword>Liver Cirrhosis</keyword>
  <keyword>Esophageal Varices</keyword>
  <keyword>Gastric Varices</keyword>
  <keyword>Portal hypertensive gastropathy</keyword>
  <keyword>Portal hypertensive enteropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Hypertension, Portal</mesh_term>
    <mesh_term>Esophageal and Gastric Varices</mesh_term>
    <mesh_term>Varicose Veins</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data can be shared after publication of the main results.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>3 years.</ipd_time_frame>
    <ipd_access_criteria>The website of the journal where the results published, and ClinicalTrials.gov web site.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03748563/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 19, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03748563/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03748563
org study id: CENTERS
nct id: NCT03748563
lead sponsor: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to
      undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is
      compared, and it will be performed within 48 hours after ds-MCE examination. The primary
      outcome is the sensitivity and specificity of ds-MCE in identifying the presence of
      esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference.
      The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV,
      red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The
      incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD
      procedures, patient satisfaction assessment and safety evaluation will also be evaluated.
Cirrhosis is the major cause of liver disease-related morbidity and mortality worldwide.
      Portal hypertension (PH) is the hemodynamic abnormality in patients with cirrhosis, which is
      associated with various pathological changes throughout the entire gastrointestinal tract,
      manifesting as esophagogastric varices (EGV), portal hypertensive gastropathy (PHG), and
      portal hypertensive enteropathy (PHE). Baveno consensus and other practice guidelines
      recommended that patients with cirrhosis undergo endoscopic screening for EGV at the time of
      diagnosis and undergo periodic surveillance endoscopy throughout the whole course of
      cirrhosis.

      Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and
      follow-up of EGV in cirrhotic patients, allowing for direct mucosal visualization and
      therapeutic intervention. EGD is however an invasive procedure and there is potential for
      procedure-related complications, such as perforation and bleeding. Besides, conscious
      sedation is always required, leading to increased cost, risk, and inconvenience for the
      patients.These factors lead to a decrease of patient compliance as well as the effectiveness
      of the screening program.

      The capsule endoscopy (CE) system provides a noninvasive and relatively comfortable approach
      to visualize the GI tract, and the development of esophageal capsule endoscopy (ECE) makes it
      possible to capture clear images of esophagus without the need of sedation. However, the
      accuracy of ECE is not currently sufficient to replace EGD for the detection and grading for
      the esophageal varices. Besides, previous studies presented that the sensitivity of ECE for
      detecting gastric varices (GVs) and PHG varies from 3% to 69%, which denoted ECE was far from
      a suitable alternative for diagnosing gastric lesions.

      To overcome these limitations, a new technique, so-called detachable string magnetically
      maneuvered capsule endoscopy (ds-MCE) was developed. The ds-MCE system consists of two parts:
      the magnetically maneuvered capsule endoscopy (MCE) system and a transparent latex sleeve
      with a hollow string. One end of the hollow string is a transparent thin latex sleeve that
      can be wrapped on the surface of the capsule, and the other end of the string is connected to
      the syringe. The capsule, which is partially enclosed within the sleeve, can be actively
      moved in the esophagus through the control of string. In this case, investigator can examine
      the entire esophageal mucosa several times under real time views. The capsule then can be
      detached from the string system through injecting air into the hollow string with the syringe
      after completing the examination of esophagus. The magnetic capsule in the stomach can be
      accurately controlled through multidimensional rotation and adaptive matching of an external
      C-arm robot. Previous studies have demonstrated that the diagnostic accuracy of MCE for
      detecting gastric focal lesions is comparable with that of conventional EGD. Two previously
      studies of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely
      viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life
      of the ds-MCE enables complete examination of the small bowel, which enables to provide a
      more comprehensive evaluation of gastrointestinal changes.

      Considering all these backgrounds, in the current prospective study, the primary aim is to
      assess the diagnostic performance of the ds-MCE in identifying the presence of EGV in
      cirrhotic patients, using EGD as the reference standard. The diagnostic accuracy of ds-MCE in
      detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV
      and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel
      under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction
      assessment and safety evaluation will also be evaluated.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Diagnostic accuracy study
primary purpose: Diagnostic
masking: None (Open Label)
measure: the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV)
time frame: 2 weeks
description: the sensitivity and specificity of ds-MCE in identifying EGV in patients with cirrhosis, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in identifying the presence of esophageal varices (EV)
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of EV, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in identifying the red sign of EV
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in identifying the red sign of EV, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in differentiating large esophageal varices
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of large EV, using the detection by EGD as the reference.
measure: the optimal esophageal luminal circumference percentage threshold under ds-MCE for distinguishing large EV
time frame: 2 weeks
description: To investigate the optimal threshold of the proportion of ds-MCE esophageal luminal circumference occupied by the largest esophageal varix present in differentiating large EV from small or no EV, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in differentiating high-risk esophageal varices
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EV, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in detection of high-risk EGV
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EGV, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in detecting gastric varices (GV)
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of GV, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in detecting cardiofundal gastric varices
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of cardiofundal GV, using the detection by EGD as the reference.
measure: the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy
time frame: 2 weeks
description: The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of portal hypertensive gastropathy (PHG), using the detection by EGD as the reference.
measure: the incidence of portal hypertensive enteropathy (PHE) under ds-MCE
time frame: 2 weeks
description: Endoscopic findings of PHE include mucosal inflammatory-like abnormalities, vascular lesions and spontaneous bleeding.
measure: the examination time of ds-MCE and EGD
time frame: 2 weeks
description: Examination time of ds-MCE include esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), small bowel transit time (SBTT), and total running time (TRT). Examination time of EGD is the time from the endoscope entering to exiting from the esophagus.
measure: patient satisfaction evaluation of the ds-MCE and EGD
time frame: 2 weeks
description: Patient satisfaction score of ds-MCE and EGD procedures.
measure: Safety evaluation
time frame: 2 weeks
description: All adverse events occurring during the study will be recorded.
arm group label: ds-MCE and EGD
arm group type: Experimental
description: All the enrolled participants will undergo the examination of detachable string magnetically maneuvered capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.
intervention type: Diagnostic Test
intervention name: ds-MCE and EGD
description: Procedure of ds-MCE:
The ds-MCE system mainly consists of two parts: the NaviCam magnetically maneuvered capsule endoscopy system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. After completing the esophageal examination, the capsule could be detached from the string through injecting air into the hollow string with the syringe. Then, the examination of stomach under magnetic control and small bowel under the natural action of gastrointestinal peristalsis follows.
Procedure of EGD:
The esophagogastroduodenoscopy (EGD) will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session.
arm group label: ds-MCE and EGD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhuan Liao
role: Principal Investigator
affiliation: Changhai Hospital
facility: 
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country: China
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: North Italian Endoscopic Club for the Study and Treatment of Esophageal Varices. Prediction of the first variceal hemorrhage in patients with cirrhosis of the liver and esophageal varices. A prospective multicenter study. N Engl J Med. 1988 Oct 13;319(15):983-9. doi: 10.1056/NEJM198810133191505.
PMID: 3262200
citation: Spina GP, Arcidiacono R, Bosch J, Pagliaro L, Burroughs AK, Santambrogio R, Rossi A. Gastric endoscopic features in portal hypertension: final report of a consensus conference, Milan, Italy, September 19, 1992. J Hepatol. 1994 Sep;21(3):461-7. doi: 10.1016/s0168-8278(05)80329-0. No abstract available.
PMID: 7836719
citation: Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607.
PMID: 1446890
citation: Kodama M, Uto H, Numata M, Hori T, Murayama T, Sasaki F, Tsubouchi N, Ido A, Shimoda K, Tsubouchi H. Endoscopic characterization of the small bowel in patients with portal hypertension evaluated by double balloon endoscopy. J Gastroenterol. 2008;43(8):589-96. doi: 10.1007/s00535-008-2198-1. Epub 2008 Aug 17.
PMID: 18709480
citation: D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.
PMID: 12939586
citation: Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available. Erratum In: Hepatology. 2007 Dec;46(6):2052.
PMID: 17879356
citation: Lapalus MG, Dumortier J, Fumex F, Roman S, Lot M, Prost B, Mion F, Ponchon T. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endoscopy. 2006 Jan;38(1):36-41. doi: 10.1055/s-2006-924975.
PMID: 16429353
citation: Gralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting esophageal disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2. Endoscopy. 2008 Apr;40(4):275-9. doi: 10.1055/s-2007-995645.
PMID: 18389444
citation: de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227.
PMID: 18435461
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Zhuan Liao
investigator title: Professor
mesh term: Liver Cirrhosis
mesh term: Hypertension, Portal
mesh term: Esophageal and Gastric Varices
mesh term: Varicose Veins
mesh term: Fibrosis
sharing ipd: Yes
ipd description: Data can be shared after publication of the main results.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 3 years.
ipd access criteria: The website of the journal where the results published, and ClinicalTrials.gov web site.
provided document: 
provided document: 