<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/NCT02967926</url>
  </required_header>
  <id_info>
    <org_study_id>791/2016</org_study_id>
    <nct_id>NCT02967926</nct_id>
  </id_info>
  <brief_title>Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy</brief_title>
  <official_title>Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to&#xD;
      facilitate common bile duct stone removal without fluoroscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients This study recruited patients who suspected/confirmed CBDS from clinical&#xD;
      manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15&#xD;
      millimeters, which measured from transabdominal ultrasonography (US), computed tomography&#xD;
      (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS).&#xD;
      The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct&#xD;
      tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All&#xD;
      patients were informed and wrote informed consent for the procedure.&#xD;
&#xD;
      Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using&#xD;
      standard side-viewing duodenoscope. After identified major papilla, the investigators&#xD;
      performed bile duct cannulation with guidewire assisted technique. Successful cannulation&#xD;
      confirmed by visualized bile aspiration. If the patients had difficult cannulation, double&#xD;
      guidewire technique was used. After the successful bile duct cannulation, the investigators&#xD;
      performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in&#xD;
      this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to&#xD;
      hilum then the investigators sweep until suspected complete CBD clearance. After that the&#xD;
      investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If&#xD;
      SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If&#xD;
      SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram&#xD;
      as reference standard for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 3</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>Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Procedural time</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Common Bile Duct Diseases</condition>
  <condition>Stone - Biliary</condition>
  <condition>Cholangitis, Sclerosing</condition>
  <arm_group>
    <arm_group_label>ERCP without Fluoroscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-fluoroscopic common bile duct stone extraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)</intervention_name>
    <description>Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal</description>
    <arm_group_label>ERCP without Fluoroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinically suspected/confirmed CBDS&#xD;
&#xD;
          -  CBD caliber 5-15 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of bile duct surgery&#xD;
&#xD;
          -  History of bile duct tumor&#xD;
&#xD;
          -  History of bile duct stricture&#xD;
&#xD;
          -  Severe comorbidity&#xD;
&#xD;
          -  Unstable vital signs&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Thanawat Luangsukrerk</investigator_full_name>
    <investigator_title>Gastrointestinal Endoscopy Excellence Center</investigator_title>
  </responsible_party>
  <keyword>common bile duct stone</keyword>
  <keyword>cholangioscopy</keyword>
  <keyword>SpyGlass</keyword>
  <keyword>non-fluoroscopic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Bile Duct Diseases</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</mesh_term>
    <mesh_term>Common Bile Duct Diseases</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</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>


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/NCT02967926
org study id: 791/2016
nct id: NCT02967926
lead sponsor: 
collaborator: 
has dmc: No
This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to
      facilitate common bile duct stone removal without fluoroscopy
Patients This study recruited patients who suspected/confirmed CBDS from clinical
      manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15
      millimeters, which measured from transabdominal ultrasonography (US), computed tomography
      (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS).
      The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct
      tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All
      patients were informed and wrote informed consent for the procedure.

      Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using
      standard side-viewing duodenoscope. After identified major papilla, the investigators
      performed bile duct cannulation with guidewire assisted technique. Successful cannulation
      confirmed by visualized bile aspiration. If the patients had difficult cannulation, double
      guidewire technique was used. After the successful bile duct cannulation, the investigators
      performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in
      this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to
      hilum then the investigators sweep until suspected complete CBD clearance. After that the
      investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If
      SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If
      SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram
      as reference standard for this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
time frame: 1 year
measure: Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
time frame: 1 year
measure: Procedural time
time frame: 1 year
arm group label: ERCP without Fluoroscopy
arm group type: Experimental
description: Non-fluoroscopic common bile duct stone extraction
intervention type: Procedure
intervention name: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)
description: Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal
arm group label: ERCP without Fluoroscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Thanawat Luangsukrerk
investigator title: Gastrointestinal Endoscopy Excellence Center
mesh term: Cholangitis
mesh term: Bile Duct Diseases
mesh term: Cholangitis, Sclerosing
mesh term: Common Bile Duct Diseases
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
mesh term: Calculi
sharing ipd: No