<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/NCT01678391</url>
  </required_header>
  <id_info>
    <org_study_id>2012.065-1</org_study_id>
    <nct_id>NCT01678391</nct_id>
  </id_info>
  <brief_title>Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy</brief_title>
  <official_title>Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California Pacific Medical Center Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>California Pacific Medical Center Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone&#xD;
      removal without use of fluoroscopy. Success for this study will be defined as the successful&#xD;
      removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will&#xD;
      only be used at the end of a presumed successful procedure to confirm that all stones are&#xD;
      removed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Successful removal of all stones from the bile duct without the use of fluoroscopy.</measure>
    <time_frame>Up to 24 hours.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Common Bile Duct Gall Stones</condition>
  <arm_group>
    <arm_group_label>Patients with common bile duct stones.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Common bile duct stone removal without fluoroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Common bile duct stone removal without fluoroscopy.</intervention_name>
    <description>ERCP stone extraction technique without fluoroscopy involves: (1) catheter or catheter with wire access into the bile duct, (2) confirmation of biliary access with catheter aspiration of bile, (3) performance of endoscopic biliary sphincterotomy or balloon dilation to widen the bile duct opening to permit stone removal, (4) stone removal - number of stones seen on EUS should match the number removed.</description>
    <arm_group_label>Patients with common bile duct stones.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients able to give informed consent&#xD;
&#xD;
          -  Patients referred to IES for the endoscopic evaluation and treatment of suspected bile&#xD;
             duct stones&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with &gt;3 bile duct stones or with any stone &gt;12mm on EUS&#xD;
&#xD;
          -  Patients with no bile duct stones on EUS&#xD;
&#xD;
          -  Patients with altered biliary anatomy (periampullary diverticulum, anomalous&#xD;
             pancreatibiliary junction, altered surgical anatomy)&#xD;
&#xD;
          -  Patients who are pregnant or breast-feeding&#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>Janak Shah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>California Pacific Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Carr-Locke DL. Overview of the role of ERCP in the management of diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2002 Dec;56(6 Suppl):S157-60. doi: 10.1067/mge.2002.129023. No abstract available.</citation>
    <PMID>12447259</PMID>
  </reference>
  <reference>
    <citation>Shelton J, Linder JD, Rivera-Alsina ME, Tarnasky PR. Commitment, confirmation, and clearance: new techniques for nonradiation ERCP during pregnancy (with videos). Gastrointest Endosc. 2008 Feb;67(2):364-8. doi: 10.1016/j.gie.2007.09.036.</citation>
    <PMID>18226705</PMID>
  </reference>
  <reference>
    <citation>Menees S, Elta G. Endoscopic retrograde cholangiopancreatography during pregnancy. Gastrointest Endosc Clin N Am. 2006 Jan;16(1):41-57. doi: 10.1016/j.giec.2006.01.004.</citation>
    <PMID>16546022</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>July 25, 2016</last_update_submitted>
  <last_update_submitted_qc>July 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>California Pacific Medical Center Research Institute</investigator_affiliation>
    <investigator_full_name>Janak Shah, MD</investigator_full_name>
    <investigator_title>Director of Pancreatic and Biliary Endoscopy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</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/NCT01678391
org study id: 2012.065-1
nct id: NCT01678391
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone
      removal without use of fluoroscopy. Success for this study will be defined as the successful
      removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will
      only be used at the end of a presumed successful procedure to confirm that all stones are
      removed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful removal of all stones from the bile duct without the use of fluoroscopy.
time frame: Up to 24 hours.
arm group label: Patients with common bile duct stones.
arm group type: Experimental
description: Common bile duct stone removal without fluoroscopy
intervention type: Procedure
intervention name: Common bile duct stone removal without fluoroscopy.
description: ERCP stone extraction technique without fluoroscopy involves: (1) catheter or catheter with wire access into the bile duct, (2) confirmation of biliary access with catheter aspiration of bile, (3) performance of endoscopic biliary sphincterotomy or balloon dilation to widen the bile duct opening to permit stone removal, (4) stone removal - number of stones seen on EUS should match the number removed.
arm group label: Patients with common bile duct stones.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janak Shah, MD
role: Principal Investigator
affiliation: California Pacific Medical Center
facility: 
country: United States
citation: Carr-Locke DL. Overview of the role of ERCP in the management of diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2002 Dec;56(6 Suppl):S157-60. doi: 10.1067/mge.2002.129023. No abstract available.
PMID: 12447259
citation: Shelton J, Linder JD, Rivera-Alsina ME, Tarnasky PR. Commitment, confirmation, and clearance: new techniques for nonradiation ERCP during pregnancy (with videos). Gastrointest Endosc. 2008 Feb;67(2):364-8. doi: 10.1016/j.gie.2007.09.036.
PMID: 18226705
citation: Menees S, Elta G. Endoscopic retrograde cholangiopancreatography during pregnancy. Gastrointest Endosc Clin N Am. 2006 Jan;16(1):41-57. doi: 10.1016/j.giec.2006.01.004.
PMID: 16546022
responsible party type: Principal Investigator
investigator affiliation: California Pacific Medical Center Research Institute
investigator full name: Janak Shah, MD
investigator title: Director of Pancreatic and Biliary Endoscopy
mesh term: Gallstones
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis