xml: <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/NCT06041113</url>
    </required_header>
    <id_info>
      <org_study_id>KY20232281-C-1</org_study_id>
      <nct_id>NCT06041113</nct_id>
    </id_info>
    <brief_title>Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones</brief_title>
    <official_title>Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones：a Long-term Retrospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Air Force Military Medical University, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Air Force Military Medical University, China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The management of coexisting intrahepatic bile duct (IBD) and extrahepatic bile duct (EBD)&#xD;
        stones is complicated and requires a multidisciplinary approach. The long-term clinical&#xD;
        outcomes of patients initially treated with endoscopic retrograde cholangiopancreatography&#xD;
        (ERCP) EBD stone extraction remain unclear. Investigators conducted a retrospective study of&#xD;
        patients with coexisting IBD and EBD to investigate the long-term impact of ERCP on the&#xD;
        incidence of recurrent EBD stones and to identify risk factors of recurrence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the recurrence rate of EBD stones</measure>
      <time_frame>up to 2 years</time_frame>
      <description>Stone recurrence was defined as new EBD stone formation beyond 3 months after complete initial clearance.</description>
    </primary_outcome>
    <enrollment type="Anticipated">104</enrollment>
    <condition>Intrahepatic Bile Duct Stone</condition>
    <condition>Choledocholithiasis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          patients with intrahepatic and extrahepatic bile duct stones who underwent ERCP&#xD;
          choledocholithotomy were eligible for our study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  non-gastrointestinal tract reconstruction patients with coexisting IBD and EBD stones&#xD;
               who underwent ERCP between July 2008 and December 2020 at Xijing Hospital in China&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with benign or malignant EBD strictures&#xD;
  &#xD;
            -  sclerosing cholangitis&#xD;
  &#xD;
            -  suspected choledochal cysts&#xD;
  &#xD;
            -  liver cirrhosis&#xD;
  &#xD;
            -  parasitic liver diseases&#xD;
  &#xD;
            -  long-term biliary drainage with biliary stents or percutaneous tubes&#xD;
  &#xD;
            -  without a definitive IBD stone or with a diagnosis of liver calcification as&#xD;
               determined by imaging review&#xD;
  &#xD;
            -  medical records or follow-up information was unavailable&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yanglin Pan, MD</last_name>
      <phone>86-29-84771536</phone>
      <email>yanglinpan@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xijing Hospital of Digestive Diseases</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yanglin Pan</last_name>
        <phone>86-29-84771536</phone>
        <email>yanglinpan@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.</citation>
      <PMID>30979521</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
      <investigator_full_name>Yanglin Pan</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>
      <mesh_term>Calculi</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041113
  org study id: KY20232281-C-1
  nct id: NCT06041113
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The management of coexisting intrahepatic bile duct (IBD) and extrahepatic bile duct (EBD)
        stones is complicated and requires a multidisciplinary approach. The long-term clinical
        outcomes of patients initially treated with endoscopic retrograde cholangiopancreatography
        (ERCP) EBD stone extraction remain unclear. Investigators conducted a retrospective study of
        patients with coexisting IBD and EBD to investigate the long-term impact of ERCP on the
        incidence of recurrent EBD stones and to identify risk factors of recurrence.
  observational model: Cohort
  time perspective: Retrospective
  measure: the recurrence rate of EBD stones
  time frame: up to 2 years
  description: Stone recurrence was defined as new EBD stone formation beyond 3 months after complete initial clearance.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Yanglin Pan, MD
  phone: 86-29-84771536
  email: yanglinpan@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.
  PMID: 30979521
  responsible party type: Principal Investigator
  investigator affiliation: Air Force Military Medical University, China
  investigator full name: Yanglin Pan
  investigator title: Professor
  mesh term: Choledocholithiasis
  mesh term: Calculi