<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/NCT01734720</url>
  </required_header>
  <id_info>
    <org_study_id>2010/533-31/2</org_study_id>
    <nct_id>NCT01734720</nct_id>
  </id_info>
  <brief_title>Common Bile Duct Stones - Natural History and Interventions</brief_title>
  <official_title>Common Bile Duct Stones - Natural History and Interventions : Data From the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangio Pancreatography (ERCP) (GallRiks)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ersta Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study were to&#xD;
&#xD;
        1. investigate what measures were taken when common bile duct stones (CBDS) were found&#xD;
           intraoperatively in Sweden during the period May 2005 to December 2009 by using data&#xD;
           from this population-based nationwide registry, and&#xD;
&#xD;
        2. analyze the outcome in terms of complications and success rates of bile duct clearance&#xD;
           in relation to various stone sizes and interventions used. In order to further&#xD;
           characterize the natural course of CBDS of various sizes, particular interest was&#xD;
           focused on patients with positive findings where no peroperative measures to clear the&#xD;
           bile ducts were taken or planned postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2005</start_date>
  <completion_date type="Actual">December 2009</completion_date>
  <primary_completion_date type="Actual">December 2009</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>complications in relation to strategy for handling CBDS</measure>
    <time_frame>30 days post operative</time_frame>
    <description>Complications reported to the registry at 30 day follow up after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complications in relation to stone size</measure>
    <time_frame>30 days post operative</time_frame>
    <description>Complications reported to the registry at 30 day follow up after surgery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3828</enrollment>
  <condition>Common Bile Duct Stone</condition>
  <arm_group>
    <arm_group_label>common bile duct stone</arm_group_label>
    <description>Patients undergoing cholecystectomy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing cholecystectomy with common bile duct stones found in peroperative&#xD;
        cholangiogram&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  common bile duct stones&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mats Möller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinsks Institutet</affiliation>
  </overall_official>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>August 28, 2013</last_update_submitted>
  <last_update_submitted_qc>August 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Mats Möller</investigator_full_name>
    <investigator_title>MD. consultant suregon, Ersta Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Calculi</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/NCT01734720
org study id: 2010/533-31/2
nct id: NCT01734720
lead sponsor: 
collaborator: 
has dmc: No
The aims of this study were to

        1. investigate what measures were taken when common bile duct stones (CBDS) were found
           intraoperatively in Sweden during the period May 2005 to December 2009 by using data
           from this population-based nationwide registry, and

        2. analyze the outcome in terms of complications and success rates of bile duct clearance
           in relation to various stone sizes and interventions used. In order to further
           characterize the natural course of CBDS of various sizes, particular interest was
           focused on patients with positive findings where no peroperative measures to clear the
           bile ducts were taken or planned postoperatively.
observational model: Cohort
time perspective: Retrospective
measure: complications in relation to strategy for handling CBDS
time frame: 30 days post operative
description: Complications reported to the registry at 30 day follow up after surgery
measure: complications in relation to stone size
time frame: 30 days post operative
description: Complications reported to the registry at 30 day follow up after surgery
arm group label: common bile duct stone
description: Patients undergoing cholecystectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
healthy volunteers: No
last name: Mats Möller, MD
role: Principal Investigator
affiliation: Karolinsks Institutet
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Mats Möller
investigator title: MD. consultant suregon, Ersta Hospital
mesh term: Gallstones
mesh term: Calculi