<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/NCT03250286</url>
  </required_header>
  <id_info>
    <org_study_id>1705-070-854</org_study_id>
    <nct_id>NCT03250286</nct_id>
  </id_info>
  <brief_title>Role of EUS in High Risk of Choledocholithiasis</brief_title>
  <official_title>Role of EUS in High Risk of Choledocholithiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woo Hyun Paik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University 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>
      The aim of this study is to demonstrate that patients with high risk of choledocholithiasis&#xD;
      who undergo ERCP only for patients with choledocholith in the EUS examination[EUS-ERCP group]&#xD;
      have less negative outcomes (including false-negative results and procedure-related&#xD;
      complications) than patients who undergo ERCP in all patients with high risk of&#xD;
      choledocholithiasis[ERCP group]. The primary outcome is the incidence of negative outcomes&#xD;
      (including false-negative results and procedure-related complications) in both groups. The&#xD;
      secondary outcomes included days of hospitalization and the rate of diagnostic ERC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies have shown that EUS testing prior to ERCP may reduce ERCP complications in&#xD;
      patients with intermediate-risk choledocholithiasis. In other words, this results obtained by&#xD;
      not performing ERCP in patients without choledocholith in the EUS examination. However, to&#xD;
      the best of our knowledge, no prospective study has been conducted on the role of EUS in&#xD;
      patients with high risk of choledocholithiasis. Therefore, we investigate the role of EUS&#xD;
      screening in patients with high risk of choledocholithiasis. We compare the negative outcomes&#xD;
      (including false negative and procedure-related complications of EUS and ERCP) of the&#xD;
      'EUS-ERCP group' in which ERCP is performed when necessary after the EUS examination and the&#xD;
      'ERCP group' in which ERCP is performed in all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">June 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 5, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>Negative outcomes associated with a false-negative diagnosis of choledocholithiasis were defined as follows: 1) diagnosis of choledocholithiasis during follow-up or 2) hospitalization for a condition likely associated with choledocholithiasis, such as biliary pancreatitis, cholangitis, or obstructive jaundice. Negative outcomes of endoscopic procedures were assessed according to the ASGE lexicon</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>Length of hospital stay</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The rate of diagnostic ERC (Endoscopic retrograde cholangiography)</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>The diagnostic ERC was defined as any ERC procedures in which no stone or sludge was removed during the procedure.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Choledocholithiasis</condition>
  <arm_group>
    <arm_group_label>EUS-ERCP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERCP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ERCP without EUS is performed in all patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EUS</intervention_name>
    <description>Endoscopic ultrasound (EUS) is performed with radial scanning echo endoscope (Olympus GF UE260) by four endosonographers.&#xD;
EUS examination is performed first, and if there is choledocholith, ERCP is performed.</description>
    <arm_group_label>EUS-ERCP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ERCP</intervention_name>
    <description>Endoscopic retrograde cholangiopancreatography (ERCP) is performed with duodenoscope (Olympus JF-260V or TJF-260V) by four endoscopists.&#xD;
In the EUS-ERCP group, ERCP is used to remove bile duct stones diagnosed via EUS. Therefore, only ERCP is performed in patients with choledocholithiasis in EUS.&#xD;
In the ERCP group, diagnosis and treatment of bile duct stones are performed with ERCP.</description>
    <arm_group_label>ERCP group</arm_group_label>
    <arm_group_label>EUS-ERCP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Abdominal CT or US showed a common bile duct diameter &gt; 6mm (&gt;8mm in patients with&#xD;
             previous cholecystectomy) and elevated total bilirubin from 1.8mg/dL to less than&#xD;
             4.0mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe mental illness&#xD;
&#xD;
          -  Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled&#xD;
             blood sugar)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Pancreatic cancer or suspected malignant tumor of the biliary tract&#xD;
&#xD;
          -  Acute pancreatitis&#xD;
&#xD;
          -  Patient who has confirmed biliary stones in abdominal ultrasonography or CT&#xD;
&#xD;
          -  Severe cholangitis according to TG 18 guideline&#xD;
&#xD;
          -  Total bilirubin &gt; 4mg/dL&#xD;
&#xD;
          -  Patients who have difficulty with EUS or ERCP due to previous gastric surgery&#xD;
             (Billroth II or TG with R-en-Y)&#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>Woo Hyun Paik, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.</citation>
    <PMID>20105473</PMID>
  </reference>
  <reference>
    <citation>He H, Tan C, Wu J, Dai N, Hu W, Zhang Y, Laine L, Scheiman J, Kim JJ. Accuracy of ASGE high-risk criteria in evaluation of patients with suspected common bile duct stones. Gastrointest Endosc. 2017 Sep;86(3):525-532. doi: 10.1016/j.gie.2017.01.039. Epub 2017 Feb 4.</citation>
    <PMID>28174126</PMID>
  </reference>
  <reference>
    <citation>Tse F, Liu L, Barkun AN, Armstrong D, Moayyedi P. EUS: a meta-analysis of test performance in suspected choledocholithiasis. Gastrointest Endosc. 2008 Feb;67(2):235-44. doi: 10.1016/j.gie.2007.09.047.</citation>
    <PMID>18226685</PMID>
  </reference>
  <reference>
    <citation>Garrow D, Miller S, Sinha D, Conway J, Hoffman BJ, Hawes RH, Romagnuolo J. Endoscopic ultrasound: a meta-analysis of test performance in suspected biliary obstruction. Clin Gastroenterol Hepatol. 2007 May;5(5):616-23. doi: 10.1016/j.cgh.2007.02.027.</citation>
    <PMID>17478348</PMID>
  </reference>
  <reference>
    <citation>De Castro VL, Moura EG, Chaves DM, Bernardo WM, Matuguma SE, Artifon EL. Endoscopic ultrasound versus magnetic resonance cholangiopancreatography in suspected choledocholithiasis: A systematic review. Endosc Ultrasound. 2016 Mar-Apr;5(2):118-28. doi: 10.4103/2303-9027.180476.</citation>
    <PMID>27080611</PMID>
  </reference>
  <reference>
    <citation>Polkowski M, Regula J, Tilszer A, Butruk E. Endoscopic ultrasound versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a randomized trial comparing two management strategies. Endoscopy. 2007 Apr;39(4):296-303. doi: 10.1055/s-2007-966264.</citation>
    <PMID>17427065</PMID>
  </reference>
  <reference>
    <citation>Adams MA, Hosmer AE, Wamsteker EJ, Anderson MA, Elta GH, Kubiliun NM, Kwon RS, Piraka CR, Scheiman JM, Waljee AK, Hussain HK, Elmunzer BJ. Predicting the likelihood of a persistent bile duct stone in patients with suspected choledocholithiasis: accuracy of existing guidelines and the impact of laboratory trends. Gastrointest Endosc. 2015 Jul;82(1):88-93. doi: 10.1016/j.gie.2014.12.023. Epub 2015 Mar 16.</citation>
    <PMID>25792387</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Woo Hyun Paik</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choledocholithiasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03250286
org study id: 1705-070-854
nct id: NCT03250286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to demonstrate that patients with high risk of choledocholithiasis
      who undergo ERCP only for patients with choledocholith in the EUS examination[EUS-ERCP group]
      have less negative outcomes (including false-negative results and procedure-related
      complications) than patients who undergo ERCP in all patients with high risk of
      choledocholithiasis[ERCP group]. The primary outcome is the incidence of negative outcomes
      (including false-negative results and procedure-related complications) in both groups. The
      secondary outcomes included days of hospitalization and the rate of diagnostic ERC.
Several studies have shown that EUS testing prior to ERCP may reduce ERCP complications in
      patients with intermediate-risk choledocholithiasis. In other words, this results obtained by
      not performing ERCP in patients without choledocholith in the EUS examination. However, to
      the best of our knowledge, no prospective study has been conducted on the role of EUS in
      patients with high risk of choledocholithiasis. Therefore, we investigate the role of EUS
      screening in patients with high risk of choledocholithiasis. We compare the negative outcomes
      (including false negative and procedure-related complications of EUS and ERCP) of the
      'EUS-ERCP group' in which ERCP is performed when necessary after the EUS examination and the
      'ERCP group' in which ERCP is performed in all patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure
time frame: 6 months after randomization
description: Negative outcomes associated with a false-negative diagnosis of choledocholithiasis were defined as follows: 1) diagnosis of choledocholithiasis during follow-up or 2) hospitalization for a condition likely associated with choledocholithiasis, such as biliary pancreatitis, cholangitis, or obstructive jaundice. Negative outcomes of endoscopic procedures were assessed according to the ASGE lexicon
measure: Length of hospital stay
time frame: 6 months after randomization
description: Length of hospital stay
measure: The rate of diagnostic ERC (Endoscopic retrograde cholangiography)
time frame: 6 months after randomization
description: The diagnostic ERC was defined as any ERC procedures in which no stone or sludge was removed during the procedure.
arm group label: EUS-ERCP group
arm group type: Experimental
description: EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.
arm group label: ERCP group
arm group type: Active Comparator
description: ERCP without EUS is performed in all patients.
intervention type: Device
intervention name: EUS
description: Endoscopic ultrasound (EUS) is performed with radial scanning echo endoscope (Olympus GF UE260) by four endosonographers.
EUS examination is performed first, and if there is choledocholith, ERCP is performed.
arm group label: EUS-ERCP group
intervention type: Device
intervention name: ERCP
description: Endoscopic retrograde cholangiopancreatography (ERCP) is performed with duodenoscope (Olympus JF-260V or TJF-260V) by four endoscopists.
In the EUS-ERCP group, ERCP is used to remove bile duct stones diagnosed via EUS. Therefore, only ERCP is performed in patients with choledocholithiasis in EUS.
In the ERCP group, diagnosis and treatment of bile duct stones are performed with ERCP.
arm group label: ERCP group
arm group label: EUS-ERCP group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Woo Hyun Paik, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
PMID: 20105473
citation: He H, Tan C, Wu J, Dai N, Hu W, Zhang Y, Laine L, Scheiman J, Kim JJ. Accuracy of ASGE high-risk criteria in evaluation of patients with suspected common bile duct stones. Gastrointest Endosc. 2017 Sep;86(3):525-532. doi: 10.1016/j.gie.2017.01.039. Epub 2017 Feb 4.
PMID: 28174126
citation: Tse F, Liu L, Barkun AN, Armstrong D, Moayyedi P. EUS: a meta-analysis of test performance in suspected choledocholithiasis. Gastrointest Endosc. 2008 Feb;67(2):235-44. doi: 10.1016/j.gie.2007.09.047.
PMID: 18226685
citation: Garrow D, Miller S, Sinha D, Conway J, Hoffman BJ, Hawes RH, Romagnuolo J. Endoscopic ultrasound: a meta-analysis of test performance in suspected biliary obstruction. Clin Gastroenterol Hepatol. 2007 May;5(5):616-23. doi: 10.1016/j.cgh.2007.02.027.
PMID: 17478348
citation: De Castro VL, Moura EG, Chaves DM, Bernardo WM, Matuguma SE, Artifon EL. Endoscopic ultrasound versus magnetic resonance cholangiopancreatography in suspected choledocholithiasis: A systematic review. Endosc Ultrasound. 2016 Mar-Apr;5(2):118-28. doi: 10.4103/2303-9027.180476.
PMID: 27080611
citation: Polkowski M, Regula J, Tilszer A, Butruk E. Endoscopic ultrasound versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a randomized trial comparing two management strategies. Endoscopy. 2007 Apr;39(4):296-303. doi: 10.1055/s-2007-966264.
PMID: 17427065
citation: Adams MA, Hosmer AE, Wamsteker EJ, Anderson MA, Elta GH, Kubiliun NM, Kwon RS, Piraka CR, Scheiman JM, Waljee AK, Hussain HK, Elmunzer BJ. Predicting the likelihood of a persistent bile duct stone in patients with suspected choledocholithiasis: accuracy of existing guidelines and the impact of laboratory trends. Gastrointest Endosc. 2015 Jul;82(1):88-93. doi: 10.1016/j.gie.2014.12.023. Epub 2015 Mar 16.
PMID: 25792387
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Woo Hyun Paik
investigator title: Professor
mesh term: Choledocholithiasis
sharing ipd: Undecided