<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/NCT01708109</url>
  </required_header>
  <id_info>
    <org_study_id>2011/873-31/3</org_study_id>
    <nct_id>NCT01708109</nct_id>
  </id_info>
  <brief_title>Optimal Handling of Common Bile Duct Calculus, a Prospective Study</brief_title>
  <official_title>Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danderyd Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sodertalje Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mora Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regional Hopspital Ryhov, Jönköping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vrinnevi Hospital, Norrköping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sundsvalls Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to study natural process of gallstones in common bile duct, stones less than&#xD;
      or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The&#xD;
      second outcome is to study side-effects of gallstones removed with surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of recruting patients to the study&#xD;
  </why_stopped>
  <start_date type="Actual">November 27, 2011</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Natural process of biliary calculus left after cholecystectomy</measure>
    <time_frame>12 month post op</time_frame>
    <description>Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications biliary calculus</measure>
    <time_frame>12 month post op</time_frame>
    <description>Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Cholelithiasis</condition>
  <arm_group>
    <arm_group_label>Biliary calculus remain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>biliary calculus, less than or equal to 6 mm, remains</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biliary calculus removed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>biliary calculus, less than or equal to 6 mm, removed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no measures taken to clear bile ductus</intervention_name>
    <description>biliary calculus remain</description>
    <arm_group_label>Biliary calculus remain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>clearance of bile ductus</intervention_name>
    <description>biliary calculus removed at surgery</description>
    <arm_group_label>Biliary calculus removed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing icterus or pancreatitis&#xD;
&#xD;
          -  History of anamneses pancreatitis/icterus&#xD;
&#xD;
          -  Allergy against x-ray contrast&#xD;
&#xD;
          -  Stones more than 6 mm in ductus&#xD;
&#xD;
          -  No passage of contrast to duodenum&#xD;
&#xD;
          -  malignant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Thorell, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Hospital Ryhov</name>
      <address>
        <city>Jönköping</city>
        <zip>SE-</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linköping University Hospital</name>
      <address>
        <city>Linköping</city>
        <zip>SE-581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mora Hospital</name>
      <address>
        <city>Mora</city>
        <zip>SE-792 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vrinnevi Hospital Norrköping</name>
      <address>
        <city>Norrköping</city>
        <zip>SE-</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ersta sjukhus</name>
      <address>
        <city>Stockholm</city>
        <zip>116 91</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danderyds Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-182 88</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundsvalls Hospital</name>
      <address>
        <city>Sundsvall</city>
        <zip>SE-</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Södertälje Hospital</name>
      <address>
        <city>Södertälje</city>
        <zip>SE-</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Anders Thorell</investigator_full_name>
    <investigator_title>Ass. Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <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/NCT01708109
org study id: 2011/873-31/3
nct id: NCT01708109
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose is to study natural process of gallstones in common bile duct, stones less than
      or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The
      second outcome is to study side-effects of gallstones removed with surgery.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Natural process of biliary calculus left after cholecystectomy
time frame: 12 month post op
description: Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
measure: Complications biliary calculus
time frame: 12 month post op
description: Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
arm group label: Biliary calculus remain
arm group type: Experimental
description: biliary calculus, less than or equal to 6 mm, remains
arm group label: Biliary calculus removed
arm group type: Experimental
description: biliary calculus, less than or equal to 6 mm, removed
intervention type: Other
intervention name: no measures taken to clear bile ductus
description: biliary calculus remain
arm group label: Biliary calculus remain
intervention type: Procedure
intervention name: clearance of bile ductus
description: biliary calculus removed at surgery
arm group label: Biliary calculus removed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anders Thorell, Assoc Prof
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Anders Thorell
investigator title: Ass. Prof.
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
mesh term: Calculi