<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/NCT04416763</url>
  </required_header>
  <id_info>
    <org_study_id>H-2005-135-1124</org_study_id>
    <nct_id>NCT04416763</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of Endoscopic Ultrasound Elastography and Contrast Enhanced Endoscopic Ultrasound for Differential Diagnosis of Gallbladder Polyp</brief_title>
  <official_title>Diagnostic Value of Endoscopic Ultrasound Elastography and Contrast Enhanced Endoscopic Ultrasound for Differential Diagnosis of Gallbladder Polyp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      Gallbladder polyps are often detected incidentally by ultrasonography. The most of&#xD;
      gallbladder polyps are non-neoplastic such as cholesterol polyps and do not need further&#xD;
      treatments. However, neoplastic polyps, which need additional treatments to prevent&#xD;
      malignancy, show the same appearance on ultrasound. Clinically, the differential diagnosis&#xD;
      between cholesterol polyps and adenomatous polyps is very important for patient follow-up and&#xD;
      treatment. However, differential diagnosis between these two conditions is difficult using&#xD;
      conventional trans-abdominal ultrasound.&#xD;
&#xD;
      Endoscopic ultrasound (EUS) is less affected and disturbed by subcutaneous fat or&#xD;
      intraabdominal air, so a clearer image of pancreatobiliary system can be obtained. In&#xD;
      addition, EUS elastography and contrast enhanced EUS are recently introduced. EUS&#xD;
      elastography enables practitioners to evaluate the stiffness of a target lesion and compare&#xD;
      it with surrounding tissues (strain ratio). Also, contrast enhanced EUS is used widely with&#xD;
      additional information such as presence of vessels and enhancement pattern of soft tissues.&#xD;
      Several studies have been published that EUS elastography can help in the differential&#xD;
      diagnosis of pancreatic solid lesions.&#xD;
&#xD;
      Although studies have been conducted to confirm the usefulness of transabdomnial ultrasound&#xD;
      with elastography or contrast enhancement at differentiating gallbladder polyps, no&#xD;
      prospective studies have been conducted to evaluate the usefulness of EUS elastography or&#xD;
      contrast enhanced EUS for gallbladder polyp. Therefore, with this prospective study, we would&#xD;
      like to evaluate the diagnostic value of EUS elastography and contrast enhanced EUS for&#xD;
      differential diagnosis of gallbladder polyps.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Pathologic diagnosis of gallbladder polyp after cholecystectomy</measure>
    <time_frame>within 10 days after operation</time_frame>
    <description>Pathologic diagnosis of gallbladder polyps or masses in cholecystectomy specimen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference of strain ratio</measure>
    <time_frame>Within two years of starting the study</time_frame>
    <description>Differences in strain ratio between non-neoplastic and neoplastic gallbladder polyps.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optimal cut-off valve of strain ratio</measure>
    <time_frame>Within two years of starting the study</time_frame>
    <description>Optimal cut-off valve of strain ratio for differential diagnosis between cholesterol polyps and adenomatous polyps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic value of EUS-elastography</measure>
    <time_frame>Within two years of starting the study</time_frame>
    <description>Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of EUS-elastography for diagnosis of cholesterol polyps.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic value of contrast enhanced EUS</measure>
    <time_frame>Within two years of starting the study</time_frame>
    <description>Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of contrast enhanced EUS for diagnosis of cholesterol polyps.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Gallbladder Polyps or Masses Greater Than 8-10 mm in Size</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have GB polyps and are recommended cholecystectomy due to large size of polyp&#xD;
        (8-10 mm or larger).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Inclusion Criteria:&#xD;
&#xD;
               1. Gallbladder polyp of 8-10mm or more in size confirmed by imaging tests&#xD;
&#xD;
               2. Must be 19 years old or older&#xD;
&#xD;
               3. With voluntary agreement to participate in the study after be informed about the&#xD;
                  necessity of EUS due to the clinical necessity&#xD;
&#xD;
          2. Exclusion Criteria:&#xD;
&#xD;
               1. Unable to confirm histological diagnosis (ex. Patients did not underwent&#xD;
                  cholecystectomy)&#xD;
&#xD;
               2. Younger than 18 year-old&#xD;
&#xD;
               3. Without agreement with this study or informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sang Hyub Lee, MD., PhD.</last_name>
    <phone>+082 2-2072-4892</phone>
    <email>gidoctor@snuh.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>101</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang Hyub Lee, MD PhD</last_name>
    </contact>
    <investigator>
      <last_name>Sang Hyub Lee, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Corwin MT, Siewert B, Sheiman RG, Kane RA. Incidentally detected gallbladder polyps: is follow-up necessary?--Long-term clinical and US analysis of 346 patients. Radiology. 2011 Jan;258(1):277-82. doi: 10.1148/radiol.10100273. Epub 2010 Aug 9.</citation>
    <PMID>20697115</PMID>
  </reference>
  <reference>
    <citation>Park CH, Chung MJ, Oh TG, Park JY, Bang S, Park SW, Kim H, Hwang HK, Lee WJ, Song SY. Differential diagnosis between gallbladder adenomas and cholesterol polyps on contrast-enhanced harmonic endoscopic ultrasonography. Surg Endosc. 2013 Apr;27(4):1414-21. doi: 10.1007/s00464-012-2620-x. Epub 2012 Dec 12.</citation>
    <PMID>23233003</PMID>
  </reference>
  <reference>
    <citation>Kozuka S, Tsubone N, Yasui A, Hachisuka K. Relation of adenoma to carcinoma in the gallbladder. Cancer. 1982 Nov 15;50(10):2226-34. doi: 10.1002/1097-0142(19821115)50:103.0.co;2-3.</citation>
    <PMID>7127263</PMID>
  </reference>
  <reference>
    <citation>Sugiyama M, Atomi Y, Kuroda A, Muto T, Wada N. Large cholesterol polyps of the gallbladder: diagnosis by means of US and endoscopic US. Radiology. 1995 Aug;196(2):493-7. doi: 10.1148/radiology.196.2.7617866.</citation>
    <PMID>7617866</PMID>
  </reference>
  <reference>
    <citation>Choi WB, Lee SK, Kim MH, Seo DW, Kim HJ, Kim DI, Park ET, Yoo KS, Lim BC, Myung SJ, Park HJ, Min YI. A new strategy to predict the neoplastic polyps of the gallbladder based on a scoring system using EUS. Gastrointest Endosc. 2000 Sep;52(3):372-9. doi: 10.1067/mge.2000.108041.</citation>
    <PMID>10968853</PMID>
  </reference>
  <reference>
    <citation>Practical Guidelines for Management of Gallbladder Polyps. Korean Journal of HBP Surgery Vol. 14, No. 3, September 2010</citation>
  </reference>
  <reference>
    <citation>Wiles R, Thoeni RF, Barbu ST, Vashist YK, Rafaelsen SR, Dewhurst C, Arvanitakis M, Lahaye M, Soltes M, Perinel J, Roberts SA. Management and follow-up of gallbladder polyps : Joint guidelines between the European Society of Gastrointestinal and Abdominal Radiology (ESGAR), European Association for Endoscopic Surgery and other Interventional Techniques (EAES), International Society of Digestive Surgery - European Federation (EFISDS) and European Society of Gastrointestinal Endoscopy (ESGE). Eur Radiol. 2017 Sep;27(9):3856-3866. doi: 10.1007/s00330-017-4742-y. Epub 2017 Feb 9.</citation>
    <PMID>28185005</PMID>
  </reference>
  <reference>
    <citation>Teber MA, Tan S, Donmez U, Ipek A, Ucar AE, Yildirim H, Aslan A, Arslan H. The use of real-time elastography in the assessment of gallbladder polyps: preliminary observations. Med Ultrason. 2014 Dec;16(4):304-8. doi: 10.11152/mu.201.3.2066.164.1mat.</citation>
    <PMID>25463882</PMID>
  </reference>
  <reference>
    <citation>Kitano M, Kudo M, Sakamoto H, Komaki T. Endoscopic ultrasonography and contrast-enhanced endoscopic ultrasonography. Pancreatology. 2011;11 Suppl 2:28-33. doi: 10.1159/000323493. Epub 2011 Apr 5.</citation>
    <PMID>21464584</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Sang Hyub Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Gallbladder polyp</keyword>
  <keyword>Endoscopic ultrasound</keyword>
  <keyword>Elastography</keyword>
  <keyword>contrast enhanced endoscopic ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
  </condition_browse>
  <!-- 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/NCT04416763
org study id: H-2005-135-1124
nct id: NCT04416763
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Gallbladder polyps are often detected incidentally by ultrasonography. The most of
      gallbladder polyps are non-neoplastic such as cholesterol polyps and do not need further
      treatments. However, neoplastic polyps, which need additional treatments to prevent
      malignancy, show the same appearance on ultrasound. Clinically, the differential diagnosis
      between cholesterol polyps and adenomatous polyps is very important for patient follow-up and
      treatment. However, differential diagnosis between these two conditions is difficult using
      conventional trans-abdominal ultrasound.

      Endoscopic ultrasound (EUS) is less affected and disturbed by subcutaneous fat or
      intraabdominal air, so a clearer image of pancreatobiliary system can be obtained. In
      addition, EUS elastography and contrast enhanced EUS are recently introduced. EUS
      elastography enables practitioners to evaluate the stiffness of a target lesion and compare
      it with surrounding tissues (strain ratio). Also, contrast enhanced EUS is used widely with
      additional information such as presence of vessels and enhancement pattern of soft tissues.
      Several studies have been published that EUS elastography can help in the differential
      diagnosis of pancreatic solid lesions.

      Although studies have been conducted to confirm the usefulness of transabdomnial ultrasound
      with elastography or contrast enhancement at differentiating gallbladder polyps, no
      prospective studies have been conducted to evaluate the usefulness of EUS elastography or
      contrast enhanced EUS for gallbladder polyp. Therefore, with this prospective study, we would
      like to evaluate the diagnostic value of EUS elastography and contrast enhanced EUS for
      differential diagnosis of gallbladder polyps.
observational model: Cohort
time perspective: Prospective
measure: Pathologic diagnosis of gallbladder polyp after cholecystectomy
time frame: within 10 days after operation
description: Pathologic diagnosis of gallbladder polyps or masses in cholecystectomy specimen
measure: Difference of strain ratio
time frame: Within two years of starting the study
description: Differences in strain ratio between non-neoplastic and neoplastic gallbladder polyps.
measure: Optimal cut-off valve of strain ratio
time frame: Within two years of starting the study
description: Optimal cut-off valve of strain ratio for differential diagnosis between cholesterol polyps and adenomatous polyps
measure: Diagnostic value of EUS-elastography
time frame: Within two years of starting the study
description: Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of EUS-elastography for diagnosis of cholesterol polyps.
measure: Diagnostic value of contrast enhanced EUS
time frame: Within two years of starting the study
description: Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of contrast enhanced EUS for diagnosis of cholesterol polyps.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sang Hyub Lee, MD., PhD.
phone: +082 2-2072-4892
email: gidoctor@snuh.org
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
citation: Corwin MT, Siewert B, Sheiman RG, Kane RA. Incidentally detected gallbladder polyps: is follow-up necessary?--Long-term clinical and US analysis of 346 patients. Radiology. 2011 Jan;258(1):277-82. doi: 10.1148/radiol.10100273. Epub 2010 Aug 9.
PMID: 20697115
citation: Park CH, Chung MJ, Oh TG, Park JY, Bang S, Park SW, Kim H, Hwang HK, Lee WJ, Song SY. Differential diagnosis between gallbladder adenomas and cholesterol polyps on contrast-enhanced harmonic endoscopic ultrasonography. Surg Endosc. 2013 Apr;27(4):1414-21. doi: 10.1007/s00464-012-2620-x. Epub 2012 Dec 12.
PMID: 23233003
citation: Kozuka S, Tsubone N, Yasui A, Hachisuka K. Relation of adenoma to carcinoma in the gallbladder. Cancer. 1982 Nov 15;50(10):2226-34. doi: 10.1002/1097-0142(19821115)50:103.0.co;2-3.
PMID: 7127263
citation: Sugiyama M, Atomi Y, Kuroda A, Muto T, Wada N. Large cholesterol polyps of the gallbladder: diagnosis by means of US and endoscopic US. Radiology. 1995 Aug;196(2):493-7. doi: 10.1148/radiology.196.2.7617866.
PMID: 7617866
citation: Choi WB, Lee SK, Kim MH, Seo DW, Kim HJ, Kim DI, Park ET, Yoo KS, Lim BC, Myung SJ, Park HJ, Min YI. A new strategy to predict the neoplastic polyps of the gallbladder based on a scoring system using EUS. Gastrointest Endosc. 2000 Sep;52(3):372-9. doi: 10.1067/mge.2000.108041.
PMID: 10968853
citation: Practical Guidelines for Management of Gallbladder Polyps. Korean Journal of HBP Surgery Vol. 14, No. 3, September 2010
citation: Wiles R, Thoeni RF, Barbu ST, Vashist YK, Rafaelsen SR, Dewhurst C, Arvanitakis M, Lahaye M, Soltes M, Perinel J, Roberts SA. Management and follow-up of gallbladder polyps : Joint guidelines between the European Society of Gastrointestinal and Abdominal Radiology (ESGAR), European Association for Endoscopic Surgery and other Interventional Techniques (EAES), International Society of Digestive Surgery - European Federation (EFISDS) and European Society of Gastrointestinal Endoscopy (ESGE). Eur Radiol. 2017 Sep;27(9):3856-3866. doi: 10.1007/s00330-017-4742-y. Epub 2017 Feb 9.
PMID: 28185005
citation: Teber MA, Tan S, Donmez U, Ipek A, Ucar AE, Yildirim H, Aslan A, Arslan H. The use of real-time elastography in the assessment of gallbladder polyps: preliminary observations. Med Ultrason. 2014 Dec;16(4):304-8. doi: 10.11152/mu.201.3.2066.164.1mat.
PMID: 25463882
citation: Kitano M, Kudo M, Sakamoto H, Komaki T. Endoscopic ultrasonography and contrast-enhanced endoscopic ultrasonography. Pancreatology. 2011;11 Suppl 2:28-33. doi: 10.1159/000323493. Epub 2011 Apr 5.
PMID: 21464584
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Sang Hyub Lee
investigator title: Professor
mesh term: Polyps