<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/NCT03244163</url>
  </required_header>
  <id_info>
    <org_study_id>SHOOT study</org_study_id>
    <nct_id>NCT03244163</nct_id>
  </id_info>
  <brief_title>Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones</brief_title>
  <official_title>Randomized Controlled Trial of Spyglass DS Peroral Cholangioscope Guided Laser Lithotripsy or Electrohydraulic Lithotripsy Versus Conventional Basket Mechanical Lithotripsy for Endoscopic Removal of Complicated Bile Duct Stones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the overall rate of endoscopic clearance of complicated bile duct&#xD;
      stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser/electrohydraulic&#xD;
      lithotripsy versus conventional BML.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, complicated bile duct stones are removed during endoscopic retrograde&#xD;
      cholangiopancreatography (ERCP) by conventional mechanical lithotripsy, which means using a&#xD;
      metal wire basket to capture the stone and crush it to make it easier to remove. This is&#xD;
      successful in approximately 70% of patients, with the success rate inversely correlated to&#xD;
      the size of the stone. Unsuccessful stone removal would require additional endoscopic,&#xD;
      percutaneous or surgical interventions. Spyglass DS peroral cholangioscope-guided holmium:YAG&#xD;
      laser/electrohydraulic lithotripsy is a recent alternate method for managing complicated bile&#xD;
      duct stones. Also performed during ERCP, a thin flexible camera (called Spyglass DS peroral&#xD;
      cholangioscope) is inserted into the bile duct to visualize the stone which can then be&#xD;
      targeted by a laser beam for fragmentation (also known as laser lithotripsy). The smaller&#xD;
      pieces are then removed. Direct comparisons of these procedures' efficacy however have not&#xD;
      been performed.&#xD;
&#xD;
      The purpose of this study is to compare the efficacy and safety of Spyglass DS peroral&#xD;
      cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy (the laser arm) versus&#xD;
      conventional basket mechanical lithotripsy alone (the conventional arm) for fragmentation and&#xD;
      clearance of complicated bile duct stones.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 14, 2016</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2026</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall rate of endoscopic bile duct stone clearance</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Overall rate of endoscopic bile duct stone clearance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical feasibility</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Technical feasibility defined as successful introduction of cholangioscope into the CBD, visualisation and laser targeting of stone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for and number of additional procedures for stone clearance</measure>
    <time_frame>6 months</time_frame>
    <description>Need for and number of additional procedures for stone clearance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Biliary Stones</condition>
  <arm_group>
    <arm_group_label>LASER ARM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONVENTIONAL ARM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stone removal by conventional techniques, for example BML, without laser lithotripsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spyglass DS cholangioscope</intervention_name>
    <description>The 1.8Fr holmium:YAG laser fiber (Lumenis, Yokneam, Israel) will be inserted into the cholangioscope's working channel for lithotripsy under direct visualization. An EHL probe may alternatively be used depending on availability. Lithotripsy is applied until fragments of the targeted stone are no longer lumen filling, and can be dispersed easily with fluid irrigation. Fragmented stones are then removed by a combination of conventional techniques. To confirm stone clearance, the Spyglass DS cholangioscope will be re-introduced, and the bile duct will be examined for residual stones from the confluence of the right and left intrahepatic ducts to the papillary opening</description>
    <arm_group_label>LASER ARM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BML</intervention_name>
    <description>Biliary sphincterotomy with/without EPBD to the size of the lower bile duct with a limit of 15mm will be performed. Stones are removed by a combination of conventional BML, extraction balloon and/or baskets, without laser lithotripsy. An occlusion cholangiogram is performed to confirm stone clearance. In cases where stone clearance is incomplete, a plastic biliary stent bridging the stone will be inserted for temporary drainage until definitive management, usually within one month.</description>
    <arm_group_label>CONVENTIONAL ARM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with complicated biliary stones&#xD;
&#xD;
          -  Patients older than 18 years old&#xD;
&#xD;
          -  Patients where informed consent can be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot give informed consent&#xD;
&#xD;
          -  Patients under 18 years old&#xD;
&#xD;
          -  Pregnant or lactating patients&#xD;
&#xD;
          -  Patient with altered gastrointestinal/biliary anatomy&#xD;
&#xD;
          -  Patients with distal CBD malignant stricture from intrinsic or extrinsic causes&#xD;
&#xD;
          -  Patients with ongoing cholangitis or biliary pancreatitis&#xD;
&#xD;
          -  Patient with refractory bleeding tendencies (Platelet count &lt;50,000/mm3 or&#xD;
             International Normalized Ratio &gt;1.5 despite correction with platelet or fresh frozen&#xD;
             plasma transfusions)&#xD;
&#xD;
          -  Patients with intrahepatic segmental stones&#xD;
&#xD;
          -  Patients with contraindications to endoscopy due to comorbidities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James LAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>John C Wong, MD</last_name>
    <phone>(852)35052931</phone>
    <email>jctwong@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Endoscopy Centre, Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>NT</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John C Wong, MD</last_name>
      <phone>(852)35052931</phone>
      <email>jctwong@cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 20, 2023</last_update_submitted>
  <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>James Yun-wong Lau</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Spyglass DS</keyword>
  <keyword>Laser lithotripsy</keyword>
  <keyword>Endoscopic retrograde cholangiopancreatography</keyword>
  <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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03244163
org study id: SHOOT study
nct id: NCT03244163
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study aims to compare the overall rate of endoscopic clearance of complicated bile duct
      stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser/electrohydraulic
      lithotripsy versus conventional BML.
Currently, complicated bile duct stones are removed during endoscopic retrograde
      cholangiopancreatography (ERCP) by conventional mechanical lithotripsy, which means using a
      metal wire basket to capture the stone and crush it to make it easier to remove. This is
      successful in approximately 70% of patients, with the success rate inversely correlated to
      the size of the stone. Unsuccessful stone removal would require additional endoscopic,
      percutaneous or surgical interventions. Spyglass DS peroral cholangioscope-guided holmium:YAG
      laser/electrohydraulic lithotripsy is a recent alternate method for managing complicated bile
      duct stones. Also performed during ERCP, a thin flexible camera (called Spyglass DS peroral
      cholangioscope) is inserted into the bile duct to visualize the stone which can then be
      targeted by a laser beam for fragmentation (also known as laser lithotripsy). The smaller
      pieces are then removed. Direct comparisons of these procedures' efficacy however have not
      been performed.

      The purpose of this study is to compare the efficacy and safety of Spyglass DS peroral
      cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy (the laser arm) versus
      conventional basket mechanical lithotripsy alone (the conventional arm) for fragmentation and
      clearance of complicated bile duct stones.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall rate of endoscopic bile duct stone clearance
time frame: Intraoperative
description: Overall rate of endoscopic bile duct stone clearance
measure: Technical feasibility
time frame: Intraoperative
description: Technical feasibility defined as successful introduction of cholangioscope into the CBD, visualisation and laser targeting of stone
measure: Incidence of adverse events
time frame: 30 days
description: Incidence of adverse events
measure: Need for and number of additional procedures for stone clearance
time frame: 6 months
description: Need for and number of additional procedures for stone clearance
arm group label: LASER ARM
arm group type: Experimental
description: Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy
arm group label: CONVENTIONAL ARM
arm group type: Active Comparator
description: Stone removal by conventional techniques, for example BML, without laser lithotripsy
intervention type: Device
intervention name: Spyglass DS cholangioscope
description: The 1.8Fr holmium:YAG laser fiber (Lumenis, Yokneam, Israel) will be inserted into the cholangioscope's working channel for lithotripsy under direct visualization. An EHL probe may alternatively be used depending on availability. Lithotripsy is applied until fragments of the targeted stone are no longer lumen filling, and can be dispersed easily with fluid irrigation. Fragmented stones are then removed by a combination of conventional techniques. To confirm stone clearance, the Spyglass DS cholangioscope will be re-introduced, and the bile duct will be examined for residual stones from the confluence of the right and left intrahepatic ducts to the papillary opening
arm group label: LASER ARM
intervention type: Device
intervention name: BML
description: Biliary sphincterotomy with/without EPBD to the size of the lower bile duct with a limit of 15mm will be performed. Stones are removed by a combination of conventional BML, extraction balloon and/or baskets, without laser lithotripsy. An occlusion cholangiogram is performed to confirm stone clearance. In cases where stone clearance is incomplete, a plastic biliary stent bridging the stone will be inserted for temporary drainage until definitive management, usually within one month.
arm group label: CONVENTIONAL ARM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: James LAU, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: John C Wong, MD
phone: (852)35052931
email: jctwong@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: James Yun-wong Lau
investigator title: Professor
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
sharing ipd: No