<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/NCT03229655</url>
  </required_header>
  <id_info>
    <org_study_id>41606</org_study_id>
    <nct_id>NCT03229655</nct_id>
  </id_info>
  <brief_title>Evaluation of Sequential Stent Addition vs. Incremental Dilation &amp; Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation</brief_title>
  <official_title>Evaluation of Sequential Stent Addition vs. Incremental Dilation &amp; Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, randomized comparison of the incremental dilation and stent exchange vs.&#xD;
      sequential stent addition approaches for management of anastomotic biliary strictures will&#xD;
      facilitate optimal management of patients who develop anastomotic biliary strictures after&#xD;
      liver transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</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>
    <intervention_model_description>Randomized prospective study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anastomotic biliary stricture resolution</measure>
    <time_frame>Immediately following final ERCP with stent removal</time_frame>
    <description>Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Fluoroscopy Time per fluoroscopy machine output</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1 week</time_frame>
    <description>Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained resolution of anastomotic stricture for 6 months</measure>
    <time_frame>6 months after final study ERCP with stent removal</time_frame>
    <description>No evidence of recurrent stricture based on clinical status and laboratory studies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained resolution of anastomotic stricture for 12 months</measure>
    <time_frame>12 months after final study ERCP with stent removal</time_frame>
    <description>No evidence of recurrent stricture based on clinical status and laboratory studies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anastomotic Stenosis</condition>
  <condition>Biliary Stricture</condition>
  <arm_group>
    <arm_group_label>Sequential stent addition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incremental Dilation &amp; Stent Exchange</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Protocol for increasing number of stents across the anastomosis</intervention_name>
    <description>Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.</description>
    <arm_group_label>Incremental Dilation &amp; Stent Exchange</arm_group_label>
    <arm_group_label>Sequential stent addition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 and older&#xD;
&#xD;
          2. Clinical concern for anastomotic biliary stricture following liver transplantation (as&#xD;
             determined by the referring transplant hepatologist)&#xD;
&#xD;
          3. Willing and able to comply with the study procedures and provide written informed&#xD;
             consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18&#xD;
&#xD;
          2. Potentially vulnerable subjects including, homeless people, pregnant females,&#xD;
             employees and students.&#xD;
&#xD;
          3. Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy,&#xD;
             Roux-en-Y-gastrojejunostomy&#xD;
&#xD;
          4. Participation in another investigational study that may directly or indirectly affect&#xD;
             the results of this study within 30 days prior to the initial visit&#xD;
&#xD;
          5. Other biliary process which accounts for patient's abnormal liver function&#xD;
             studies/imaging (i.e. significant non-anastomotic biliary stricture).&#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_contact>
    <last_name>Subhas Banerjee, MD</last_name>
    <phone>650-723-2623</phone>
    <email>sbanerje@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Subhas Banerjee, MD</last_name>
      <phone>650-723-2623</phone>
      <email>sbanerje@stanford.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>September 8, 2018</last_update_submitted>
  <last_update_submitted_qc>September 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Subhas Banerjee</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, Division of Gastroenterology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT03229655
org study id: 41606
nct id: NCT03229655
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, randomized comparison of the incremental dilation and stent exchange vs.
      sequential stent addition approaches for management of anastomotic biliary strictures will
      facilitate optimal management of patients who develop anastomotic biliary strictures after
      liver transplantation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized prospective study
primary purpose: Treatment
masking: None (Open Label)
measure: Anastomotic biliary stricture resolution
time frame: Immediately following final ERCP with stent removal
description: Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed
measure: Fluoroscopy Parameters
time frame: 1 day
description: Fluoroscopy Time per fluoroscopy machine output
measure: Adverse Events
time frame: 1 week
description: Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure
measure: Sustained resolution of anastomotic stricture for 6 months
time frame: 6 months after final study ERCP with stent removal
description: No evidence of recurrent stricture based on clinical status and laboratory studies
measure: Sustained resolution of anastomotic stricture for 12 months
time frame: 12 months after final study ERCP with stent removal
description: No evidence of recurrent stricture based on clinical status and laboratory studies
arm group label: Sequential stent addition
arm group type: Experimental
description: ERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation.
arm group label: Incremental Dilation & Stent Exchange
arm group type: Active Comparator
description: ERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge.
intervention type: Procedure
intervention name: Protocol for increasing number of stents across the anastomosis
description: Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.
arm group label: Incremental Dilation & Stent Exchange
arm group label: Sequential stent addition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Subhas Banerjee, MD
phone: 650-723-2623
email: sbanerje@stanford.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Subhas Banerjee
investigator title: Associate Professor of Medicine, Division of Gastroenterology
mesh term: Cholestasis
mesh term: Constriction, Pathologic
sharing ipd: No