<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/NCT04467710</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0001</org_study_id>
    <nct_id>NCT04467710</nct_id>
  </id_info>
  <brief_title>Laparoscopic Treatment of Common Bile Duct Stones : What Are the Limits and When Should we Call the Endoscopist ?</brief_title>
  <official_title>Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 was to identify some risk factors of failure of surgical management of&#xD;
      common bile duct stones, in our center between 2007 and 2019.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lithiasis disease represents a real public health problem. Indeed, 10% of the general&#xD;
      population is asymptomatic carrier of gallbladder stones and among them, 35% will present a&#xD;
      symptomatic form which will cause the indication of cholecystectomy. As a result, around&#xD;
      120,000 cholecystectomies are performed per year in France, and around 750,000 in the United&#xD;
      States for this indication. Cholecystectomy is therefore the most widely performed procedure&#xD;
      in the world. However, in 3 to 20% of cases, common bile duct stones will be associated and&#xD;
      to be treated. Different strategies are proposed: a treatment called &quot;all surgical&quot; or an&#xD;
      endoscopic treatment (usually a sphincterotomy) before, after or during a cholecystectomy.&#xD;
      The investigators defined two groups of patients: one group with success of fully&#xD;
      laparoscopic surgical treatment (cholecystectomy and laparoscopic exploration of the common&#xD;
      bile duct at the same time), and one group treated by laparoscopic cholecystectomy and&#xD;
      management of the common bile duct stone(s) by an ERCP performed intra, per ou&#xD;
      postoperatively. The primary outcome was the failure of surgical management, defined as the&#xD;
      requirement of ERCP for extraction of common bile duct stones, which permit us to identify&#xD;
      risk factors of failure in the fullfil surgical treatment process. The secondary outcome was&#xD;
      to study the morbimortality in each group, and length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2007</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>morbimortality</measure>
    <time_frame>1 day</time_frame>
    <description>Clavien dindo classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>risk factors of total laprascopic treatment failure.</measure>
    <time_frame>1 day</time_frame>
    <description>risk factors of total laprascopic treatment failure.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">222</enrollment>
  <condition>Laparoscopic</condition>
  <condition>Common Bile Duct Stone With Chronic Cholecystitis</condition>
  <arm_group>
    <arm_group_label>Success of LCBDE</arm_group_label>
    <description>Patients with a fully laparoscopic surgical treatment of common bile duct stones</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Failure of LCBDE</arm_group_label>
    <description>Patients with a laparoscopic cholecystectomy but an endoscopic treatment of common bile duct stone with an ERCP performed intra, per or postoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic common bile duct exploration.</intervention_name>
    <description>Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct.&#xD;
ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time.</description>
    <arm_group_label>Failure of LCBDE</arm_group_label>
    <arm_group_label>Success of LCBDE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients aged more than 18, hospitalized in Montpellier University Hospital between&#xD;
        2007 and 2019 requiring a laparoscopic cholecystectomy for symptomatic biliary disease&#xD;
        associated to a common bile duct stone highlighted on preoperative imaging or&#xD;
        intraoperative cholangiography, which will be treated surgically or endoscopically during&#xD;
        the same hospital stay.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  More than 18 years old&#xD;
&#xD;
          -  Between 2007 and 2019&#xD;
&#xD;
          -  Montpellier University Hospital&#xD;
&#xD;
          -  Laparoscopic cholecystectomy for symptomatic cholelithiasis associated to common bile&#xD;
             duct stones&#xD;
&#xD;
          -  Common bile duct stones highlighted on preoperative imaging or intraoperative&#xD;
             cholangiography&#xD;
&#xD;
          -  Common bile duct stones treated during the same hospital stay surgically or&#xD;
             endocopically&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Laparotomy&#xD;
&#xD;
          -  Previous ERCP&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Lost to follow up&#xD;
&#xD;
          -  Lack of data &gt; 10%&#xD;
&#xD;
          -  Other surgical procedure associated at the same time&#xD;
&#xD;
          -  Previous cholecystectomy&#xD;
&#xD;
          -  Caroli's disease&#xD;
&#xD;
          -  Severe cholangitis or acute pancreatitis&#xD;
&#xD;
          -  Pigmentary or hydatic lithiasis&#xD;
&#xD;
          -  Laparoscopic cholecystectomy for other indication than symptomatic cholelithiasis&#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>Astrid HERRERO, MD, PHD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Common bile duct stones</keyword>
  <keyword>Laparoscopic common bile duct exploration (LCBDE)</keyword>
  <keyword>ERCP</keyword>
  <keyword>Morbimortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04467710
org study id: RECHMPL20_0001
nct id: NCT04467710
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to identify some risk factors of failure of surgical management of
      common bile duct stones, in our center between 2007 and 2019.
Lithiasis disease represents a real public health problem. Indeed, 10% of the general
      population is asymptomatic carrier of gallbladder stones and among them, 35% will present a
      symptomatic form which will cause the indication of cholecystectomy. As a result, around
      120,000 cholecystectomies are performed per year in France, and around 750,000 in the United
      States for this indication. Cholecystectomy is therefore the most widely performed procedure
      in the world. However, in 3 to 20% of cases, common bile duct stones will be associated and
      to be treated. Different strategies are proposed: a treatment called "all surgical" or an
      endoscopic treatment (usually a sphincterotomy) before, after or during a cholecystectomy.
      The investigators defined two groups of patients: one group with success of fully
      laparoscopic surgical treatment (cholecystectomy and laparoscopic exploration of the common
      bile duct at the same time), and one group treated by laparoscopic cholecystectomy and
      management of the common bile duct stone(s) by an ERCP performed intra, per ou
      postoperatively. The primary outcome was the failure of surgical management, defined as the
      requirement of ERCP for extraction of common bile duct stones, which permit us to identify
      risk factors of failure in the fullfil surgical treatment process. The secondary outcome was
      to study the morbimortality in each group, and length of stay.
observational model: Case-Control
time perspective: Retrospective
measure: morbimortality
time frame: 1 day
description: Clavien dindo classification
measure: risk factors of total laprascopic treatment failure.
time frame: 1 day
description: risk factors of total laprascopic treatment failure.
arm group label: Success of LCBDE
description: Patients with a fully laparoscopic surgical treatment of common bile duct stones
arm group label: Failure of LCBDE
description: Patients with a laparoscopic cholecystectomy but an endoscopic treatment of common bile duct stone with an ERCP performed intra, per or postoperatively
intervention type: Procedure
intervention name: Laparoscopic common bile duct exploration.
description: Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct.
ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time.
arm group label: Failure of LCBDE
arm group label: Success of LCBDE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Astrid HERRERO, MD, PHD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Cholecystitis
mesh term: Calculi
sharing ipd: Undecided
ipd description: NC