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/NCT06011941</url>
    </required_header>
    <id_info>
      <org_study_id>81524</org_study_id>
      <nct_id>NCT06011941</nct_id>
    </id_info>
    <brief_title>Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis</brief_title>
    <official_title>Safety and Feasibility of Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</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 modified laparoscopic transcystic biliary drainage which we developed in the treatment of&#xD;
        cholecystocholedocholithiasis has some advantages over conventional techniques.&#xD;
  &#xD;
        Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional&#xD;
        5-Fr ureteral catheter, which extended the function of the C-tube.&#xD;
  &#xD;
        Then we developed a continued suture and circling manner by the V-Loc closure device, which&#xD;
        simultaneously covered and anchored the C-tube.&#xD;
  &#xD;
        Theoretically, this modified laparoscopic transcystic drainage not only provide safe and&#xD;
        effective bile duct drainage, but also provide a convenient access of treatment for&#xD;
        postoperatively retained bile duct stones, which may expand the indication of initially&#xD;
        laparoscopic operation in the management of cholecysto-choledocholithiasis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The modified laparoscopic transcystic biliary drainage which we developed in the treatment of&#xD;
        cholecystocholedocholithiasis has some advantages over conventional techniques.&#xD;
  &#xD;
        Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International&#xD;
        Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended&#xD;
        the function of the C-tube.&#xD;
  &#xD;
        Then we developed a continued suture and circling manner by the V-Loc closure device&#xD;
        (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the&#xD;
        C-tube.&#xD;
  &#xD;
        Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the&#xD;
        costal margin on the midaxillary line/the posterior axillary line, which was traditionally&#xD;
        performed at the point below the midclavicular line on the right side. Our modified path&#xD;
        could avoid the compression of the C-tube by hepatic margin and hence decrease the&#xD;
        dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence&#xD;
        development and sinus-tract formation.&#xD;
  &#xD;
        More importantly, this path could easily be available when the patient be placed in the prone&#xD;
        position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube&#xD;
        down to the duodenum to perform postoperative rendezvous technique.&#xD;
  &#xD;
        Theoretically, this modified laparoscopic transcystic drainage not only provide safe and&#xD;
        effective bile duct drainage, but also provide a convenient access of treatment for&#xD;
        postoperatively retained bile duct stones, which may expand the indication of initially&#xD;
        laparoscopic operation in the management of cholecysto-choledocholithiasis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">July 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative overall morbidity</measure>
      <time_frame>6 months</time_frame>
      <description>All outcome variables will be assessed according to internationally accepted standards if available, that is, the consensus definitions for surgical and medical complications according to the Clavien-Dindo classification.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>bile leakage</measure>
      <time_frame>6 months</time_frame>
      <description>Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>anchoring time of the C-tube</measure>
      <time_frame>6 months</time_frame>
      <description>the consumption of time from needle puncture to ending of C-tube ligation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>average daily drainage volume</measure>
      <time_frame>6 months</time_frame>
      <description>the average volume of bile drainage per day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>early dislodgement of C-tube</measure>
      <time_frame>6 months</time_frame>
      <description>the dislodgement of C-tube before intended removal.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">310</enrollment>
    <condition>Common Bile Duct Calculi</condition>
    <condition>Acute; Cholecystitis, Choledocholithiasis</condition>
    <condition>Acute Cholecystitis With Obstruction</condition>
    <condition>Acute Cholangitis</condition>
    <arm_group>
      <arm_group_label>modified laparoscopic transcystic biliary drainage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Modified laparoscopic transcystic biliary drainage</intervention_name>
      <description>First, a needle was passed through a separate skin puncture wound 3 cm below the costal margin on the midaxillary line/posterior axillary line. Second, a lateral incision into the cystic duct was performed medially to allow insertion and embedding of the catheter. Third, a 7-Fr catheter was introduced through the abdominal wall via the cystic duct into the CBD. Fourth, if the position of the catheter inside the CBD was correct (the end of the tube reached the distal CBD but did not pass the papilla), the lateral incision of the cystic duct was closed by a V-Loc closure device using a single-layered, continuous suture in a circling manner to simultaneously cover and anchor the C-tube. After the procedure, an artificial fistula of 3 to 5 mm in length was formed.</description>
      <arm_group_label>modified laparoscopic transcystic biliary drainage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients ≥ 18 years of age;&#xD;
  &#xD;
            -  Patients with gallbladder stones and known or expected concomitant bile duct stones;&#xD;
  &#xD;
            -  Informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Biliary drainage is already present, e.g. preoperative ENBD, PTCD;&#xD;
  &#xD;
            -  Women who are pregnant;&#xD;
  &#xD;
            -  Declined consent;&#xD;
  &#xD;
            -  Inability to follow the procedures of the study, e.g. due to language problems and&#xD;
               psychological disorders of the participant;&#xD;
  &#xD;
            -  Morbid obesity (BMI &gt; 40);&#xD;
  &#xD;
            -  IV-VI class of the American Society of Anesthesiologists physical status&#xD;
               classification;&#xD;
  &#xD;
            -  Contraindications for general anesthesia or surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>LINGFU ZHANG</last_name>
      <role>Study Chair</role>
      <affiliation>北京大学第三医院</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>LINGFU ZHANG</last_name>
      <phone>+8613488693608</phone>
      <email>zhanglingfuzlf@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Lingfu Zhang</name>
        <address>
          <city>Beijing</city>
          <state>None Selected</state>
          <zip>100191</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>LINGFU ZHANG</last_name>
        <phone>+8613488693608</phone>
        <email>zhanglingfuzlf@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Zhang LF, Hou CS, Xu Z, Wang LX, Ling XF, Wang G, Cui L, Xiu DR. [Clinical effect of laparoscopic transcystic drainage combined with common bile duct exploration for the patients with difficult biliary stones]. Beijing Da Xue Xue Bao Yi Xue Ban. 2022 Dec 18;54(6):1185-1189. doi: 10.19723/j.issn.1671-167X.2022.06.021. Chinese.</citation>
      <PMID>36533353</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholangitis</mesh_term>
      <mesh_term>Cholecystitis</mesh_term>
      <mesh_term>Acalculous Cholecystitis</mesh_term>
      <mesh_term>Cholecystitis, Acute</mesh_term>
      <mesh_term>Choledocholithiasis</mesh_term>
      <mesh_term>Gallstones</mesh_term>
      <mesh_term>Calculi</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06011941
  org study id: 81524
  nct id: NCT06011941
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The modified laparoscopic transcystic biliary drainage which we developed in the treatment of
        cholecystocholedocholithiasis has some advantages over conventional techniques.
  
        Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional
        5-Fr ureteral catheter, which extended the function of the C-tube.
  
        Then we developed a continued suture and circling manner by the V-Loc closure device, which
        simultaneously covered and anchored the C-tube.
  
        Theoretically, this modified laparoscopic transcystic drainage not only provide safe and
        effective bile duct drainage, but also provide a convenient access of treatment for
        postoperatively retained bile duct stones, which may expand the indication of initially
        laparoscopic operation in the management of cholecysto-choledocholithiasis.
  The modified laparoscopic transcystic biliary drainage which we developed in the treatment of
        cholecystocholedocholithiasis has some advantages over conventional techniques.
  
        Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International
        Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended
        the function of the C-tube.
  
        Then we developed a continued suture and circling manner by the V-Loc closure device
        (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the
        C-tube.
  
        Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the
        costal margin on the midaxillary line/the posterior axillary line, which was traditionally
        performed at the point below the midclavicular line on the right side. Our modified path
        could avoid the compression of the C-tube by hepatic margin and hence decrease the
        dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence
        development and sinus-tract formation.
  
        More importantly, this path could easily be available when the patient be placed in the prone
        position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube
        down to the duodenum to perform postoperative rendezvous technique.
  
        Theoretically, this modified laparoscopic transcystic drainage not only provide safe and
        effective bile duct drainage, but also provide a convenient access of treatment for
        postoperatively retained bile duct stones, which may expand the indication of initially
        laparoscopic operation in the management of cholecysto-choledocholithiasis.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: postoperative overall morbidity
  time frame: 6 months
  description: All outcome variables will be assessed according to internationally accepted standards if available, that is, the consensus definitions for surgical and medical complications according to the Clavien-Dindo classification.
  measure: bile leakage
  time frame: 6 months
  description: Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.
  measure: anchoring time of the C-tube
  time frame: 6 months
  description: the consumption of time from needle puncture to ending of C-tube ligation
  measure: average daily drainage volume
  time frame: 6 months
  description: the average volume of bile drainage per day
  measure: early dislodgement of C-tube
  time frame: 6 months
  description: the dislodgement of C-tube before intended removal.
  arm group label: modified laparoscopic transcystic biliary drainage
  arm group type: Experimental
  description: A 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side.
  intervention type: Procedure
  intervention name: Modified laparoscopic transcystic biliary drainage
  description: First, a needle was passed through a separate skin puncture wound 3 cm below the costal margin on the midaxillary line/posterior axillary line. Second, a lateral incision into the cystic duct was performed medially to allow insertion and embedding of the catheter. Third, a 7-Fr catheter was introduced through the abdominal wall via the cystic duct into the CBD. Fourth, if the position of the catheter inside the CBD was correct (the end of the tube reached the distal CBD but did not pass the papilla), the lateral incision of the cystic duct was closed by a V-Loc closure device using a single-layered, continuous suture in a circling manner to simultaneously cover and anchor the C-tube. After the procedure, an artificial fistula of 3 to 5 mm in length was formed.
  arm group label: modified laparoscopic transcystic biliary drainage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: LINGFU ZHANG
  role: Study Chair
  affiliation: 北京大学第三医院
  last name: LINGFU ZHANG
  phone: +8613488693608
  email: zhanglingfuzlf@126.com
  facility: 
  contact: 
  country: China
  citation: Zhang LF, Hou CS, Xu Z, Wang LX, Ling XF, Wang G, Cui L, Xiu DR. [Clinical effect of laparoscopic transcystic drainage combined with common bile duct exploration for the patients with difficult biliary stones]. Beijing Da Xue Xue Bao Yi Xue Ban. 2022 Dec 18;54(6):1185-1189. doi: 10.19723/j.issn.1671-167X.2022.06.021. Chinese.
  PMID: 36533353
  responsible party type: Sponsor
  mesh term: Cholangitis
  mesh term: Cholecystitis
  mesh term: Acalculous Cholecystitis
  mesh term: Cholecystitis, Acute
  mesh term: Choledocholithiasis
  mesh term: Gallstones
  mesh term: Calculi
  sharing ipd: No