<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/NCT02189421</url>
  </required_header>
  <id_info>
    <org_study_id>SCHBC 2014-06-012-001</org_study_id>
    <nct_id>NCT02189421</nct_id>
  </id_info>
  <brief_title>Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy</brief_title>
  <official_title>Comparison of Multibending and Conventional Ultra-slim Upper Endoscope for the Direct Advance Into the Bile Duct Without Assisting Accessory in Peroral Cholangioscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the usefulness of a newly developed multibending&#xD;
      ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without&#xD;
      assisting accessory in comparison with conventional ultra-slim endoscope. The investigators&#xD;
      expect that multibending endoscope will show more higher successful performance than&#xD;
      conventional endoscope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Direct POC using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic&#xD;
      intraductal interventions under direct endoscopic visualization in selected patients who has&#xD;
      dilated distal CBD and widened papillary orifice. Because the bile duct has anatomical&#xD;
      position in acute angle with the duodenum, assisting accessories such as intraductal&#xD;
      anchoring balloon, guidewire or overtube is usually required for the successful direct POC.&#xD;
      Recently, direct peroral cholangioscopes have been developed for free-hand direct advancement&#xD;
      of the endoscope into the bile duct from duodenum. Multibending ultra-slim endoscope may be&#xD;
      expected to facilitate the advance into the bile duct by overcoming the acute angle between&#xD;
      the bile duct and the duodenum. After randomization of enrolled patients into two groups,&#xD;
      direct POC will be performed by using a conventional slim endoscope in control group and by&#xD;
      using a multibending endoscope in study group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical success of the direct peroral cholangioscopy</measure>
    <time_frame>6 months</time_frame>
    <description>Successful insertion of a slim endoscope into the bile duct in no assisting accessories.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events associated with direct POC</measure>
    <time_frame>6 months</time_frame>
    <description>Cholangitis: fever and abdominal pain with abnormal liver function test&#xD;
Hemobilia: bleeding from the bile duct&#xD;
Pancreatitis: abdominal pain with elevation of the serum amylase and lipase&#xD;
Bile duct perforation: any evidence of bile duct perforation in imaging studies.&#xD;
Air embolism: clinical and imagine findings with air embolism</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Common Bile Duct Calculi</condition>
  <condition>Biliary Tract Cancer</condition>
  <condition>Biliary Stricture</condition>
  <condition>Bile Duct Diseases</condition>
  <arm_group>
    <arm_group_label>Direct peroral cholangioscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultra-slim upper endoscope</intervention_name>
    <description>Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories</description>
    <arm_group_label>Direct peroral cholangioscopy</arm_group_label>
    <other_name>CHF-Y0009</other_name>
    <other_name>GIF-XP290N</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pancreatobiliary diseases that are indicated for direct POC&#xD;
&#xD;
          -  The patient who aged from 20 to 80 years. Legally acceptable representative must be&#xD;
             capable of giving written informed consent prior to participation in this study&#xD;
&#xD;
          -  The woman of child-bearing age must be negative from the pregnancy test in order to&#xD;
             participate in this study&#xD;
&#xD;
          -  Dilated common bile duct (&gt; 8 mm)&#xD;
&#xD;
          -  Having previous sphincterotomy and/or papillary balloon dilation&#xD;
&#xD;
          -  The patients should not have any unacceptable conditions (e.g., physiological,&#xD;
             familyish, social, geographical) for medical follow-up and adaptation of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated for ERCP&#xD;
&#xD;
          -  Patients with stricture on papillary orifice&#xD;
&#xD;
          -  Patients with periampullary malignancy&#xD;
&#xD;
          -  Bleeding tendency: International normalized ratio (INR) of prothrombin time &lt; 1.5 or&#xD;
             platelet count &lt; 60,000/mm3&#xD;
&#xD;
          -  Patients with other serious disease or medical condition&#xD;
&#xD;
          -  Patients with past medical history of significant neurologic or Psychiatric disorders&#xD;
             such as dementia or seizure&#xD;
&#xD;
          -  Unstable heart disease despite of treatment, recent myocardial infarction within 6&#xD;
             month (Even though MI was diagnosed within 6 months, if it becomes stable presently,&#xD;
             the patient can be possible to participate).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Ho Moon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SoonChunHyang University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soonchunhyang University Bucheon Hospital</name>
      <address>
        <city>Bucheon</city>
        <zip>420-767</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>October 30, 2015</last_update_submitted>
  <last_update_submitted_qc>October 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Hyun Jong Choi</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>peroral cholangioscopy</keyword>
  <keyword>ultra-slim upper endoscope</keyword>
  <keyword>multibending endoscope</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
    <mesh_term>Bile Duct Diseases</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/NCT02189421
org study id: SCHBC 2014-06-012-001
nct id: NCT02189421
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the usefulness of a newly developed multibending
      ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without
      assisting accessory in comparison with conventional ultra-slim endoscope. The investigators
      expect that multibending endoscope will show more higher successful performance than
      conventional endoscope.
Direct POC using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic
      intraductal interventions under direct endoscopic visualization in selected patients who has
      dilated distal CBD and widened papillary orifice. Because the bile duct has anatomical
      position in acute angle with the duodenum, assisting accessories such as intraductal
      anchoring balloon, guidewire or overtube is usually required for the successful direct POC.
      Recently, direct peroral cholangioscopes have been developed for free-hand direct advancement
      of the endoscope into the bile duct from duodenum. Multibending ultra-slim endoscope may be
      expected to facilitate the advance into the bile duct by overcoming the acute angle between
      the bile duct and the duodenum. After randomization of enrolled patients into two groups,
      direct POC will be performed by using a conventional slim endoscope in control group and by
      using a multibending endoscope in study group.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Technical success of the direct peroral cholangioscopy
time frame: 6 months
description: Successful insertion of a slim endoscope into the bile duct in no assisting accessories.
measure: Adverse events associated with direct POC
time frame: 6 months
description: Cholangitis: fever and abdominal pain with abnormal liver function test
Hemobilia: bleeding from the bile duct
Pancreatitis: abdominal pain with elevation of the serum amylase and lipase
Bile duct perforation: any evidence of bile duct perforation in imaging studies.
Air embolism: clinical and imagine findings with air embolism
arm group label: Direct peroral cholangioscopy
arm group type: Other
description: Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
intervention type: Device
intervention name: ultra-slim upper endoscope
description: Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
arm group label: Direct peroral cholangioscopy
other name: CHF-Y0009
other name: GIF-XP290N
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jong Ho Moon, MD, PhD
role: Principal Investigator
affiliation: SoonChunHyang University School of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Hyun Jong Choi
investigator title: Assistant professor
mesh term: Biliary Tract Neoplasms
mesh term: Bile Duct Diseases
mesh term: Gallstones
mesh term: Calculi