<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/NCT03279809</url>
  </required_header>
  <id_info>
    <org_study_id>H-1707-161-874</org_study_id>
    <nct_id>NCT03279809</nct_id>
  </id_info>
  <brief_title>The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction</brief_title>
  <official_title>The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woo Hyun Paik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      The aim of this study is to determine whether administration of aspirin can help maintain the&#xD;
      patency of metallic stents for distal malignant common bile duct obstruction. Metal stents&#xD;
      are mainly used for malignant biliary obstruction if the surgical treatment is not considered&#xD;
      and its maintenance period has been reported to be about 8 months. This study will be&#xD;
      prospectively conducted as a randomized controlled study with aspirin treated patients who&#xD;
      received metal stents in patients over 20 years who were confirmed malignant distal biliary&#xD;
      obstruction. The primary endpoint is the incidence of stent dysfunction in both groups for 6&#xD;
      months after the procedure. The secondary endpoints included duration of metallic stent&#xD;
      patency, incidence of further procedures, and adverse events related with aspirin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background -Endoscopic drainage is the first choice for bile drainage in patients with&#xD;
      malignant distal biliary obstruction. Metal stents are mainly used for malignant biliary&#xD;
      obstruction if the surgical treatment is not considered. Metal stents have proven superior in&#xD;
      many clinical aspects over plastic stents. Nonetheless, the maintenance period of the&#xD;
      metallic stent patency has been reported to be around 8 months, and it is often necessary to&#xD;
      undergo further procedure due to dysfunction of stents. Recently, it has been reported that&#xD;
      the duration of the metallic stent patency in patients with aspirin is prolonged. Since the&#xD;
      previous study was a retrospective study, this study will be prospectively conducted as a&#xD;
      randomized controlled study with aspirin treated patients who received metal stents in&#xD;
      patients over 20 years who were confirmed malignant distal biliary obstruction. The incidence&#xD;
      of stent dysfunction in both groups for 6 months after the procedure will be compared. Stent&#xD;
      dysfunction is defined as any case which further procedure is required due to jaundice or&#xD;
      cholangitis after stent insertion.&#xD;
&#xD;
      Study aim&#xD;
&#xD;
      -The aim of this study is to determine whether administration of aspirin can help maintain&#xD;
      the patency of metallic stents for distal malignant common bile duct obstruction.&#xD;
&#xD;
      Data analysis&#xD;
&#xD;
        -  Blinding will remain in place until the statistician codes the statistical analyses of&#xD;
           the primary and secondary outcomes. The statistical analyses will be done using the full&#xD;
           analysis set according to the intention-to-treat principle, meaning all the randomized&#xD;
           patients will be analyzed in their allocated groups regardless of any protocol&#xD;
           violations or early treatment discontinuations. The outcomes through a per-protocol&#xD;
           analysis set that will consider only the subjects who followed the protocol effectively&#xD;
           will be analyzed.&#xD;
&#xD;
        -  The rate of stent dysfunction will be compared using Pearson's chi-squared test with&#xD;
           Fisher's exact test and calculated the odds ratio of the event. The secondary outcomes&#xD;
           (i.e., the duration of stent patency, the rate of reintervention, and the adverse events&#xD;
           related to aspirin administration) will be analyzed using Pearson's chi-squared test&#xD;
           with Fisher's exact test, Student's t-test, and Kaplan-Meier curves stratified by drug&#xD;
           and the hazard ratios between two groups using the Cox proportional hazards. The further&#xD;
           affecting factors for stent dysfunction will be assessed by univariable and&#xD;
           multivariable logistic regression analysis.&#xD;
&#xD;
        -  In the initial plan, it was decided not to perform interim analysis, but it was&#xD;
           confirmed that more adverse events occurred than expected in the process of conducting&#xD;
           the study. Therefore, the interim analysis was performed with the data up to May 2020,&#xD;
           and determine whether to continue the study by measuring the benefits and losses&#xD;
           obtained from aspirin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    One grade 4 adverse event (AE) and common (47.2%) grade 3 AEs&#xD;
  </why_stopped>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">September 5, 2020</completion_date>
  <primary_completion_date type="Actual">September 5, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of stent dysfunction</measure>
    <time_frame>6 months after biliary metalic stent</time_frame>
    <description>Dysfunction after 6 months from stenting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of metalic stent patency</measure>
    <time_frame>6 months after biliary metalic stent</time_frame>
    <description>Duration from insertion time to metallic stent dysfunction time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of further procedures</measure>
    <time_frame>6 months after biliary metalic stent</time_frame>
    <description>Incidence of further procedures needed for biliary drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events related with aspirin</measure>
    <time_frame>6 months after biliary metalic stent</time_frame>
    <description>Adverse events which clearly related with aspirin admistration including bleeding event</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Biliary Stasis, Extrahepatic</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention : aspirin medication Case with aspirin medication for 6 months after stenting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control : placebo medication Case with placebo medication for 6 months after stenting</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Aspirin 100 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Case with placebo medication for 6 months after stenting</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Placebo drug of aspirin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malignant distal bile duct obstruction&#xD;
&#xD;
          -  Over 20 years old&#xD;
&#xD;
          -  Techinical success of endoscopic retrograde biliary drainage with metalic stent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's denial&#xD;
&#xD;
          -  Previous Aspirin use&#xD;
&#xD;
          -  Aspirin allergy&#xD;
&#xD;
          -  Contraindication for aspirin&#xD;
&#xD;
          -  Life expectancy &lt; 6mo&#xD;
&#xD;
          -  Gastroduodenal ulcer&#xD;
&#xD;
          -  History of substance abuse&#xD;
&#xD;
          -  Participation in a clinical trial within the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Woo Hyun Paik, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Jongno-gu</state>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Woo Hyun Paik</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Cholestasis, Extrahepatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03279809
org study id: H-1707-161-874
nct id: NCT03279809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine whether administration of aspirin can help maintain the
      patency of metallic stents for distal malignant common bile duct obstruction. Metal stents
      are mainly used for malignant biliary obstruction if the surgical treatment is not considered
      and its maintenance period has been reported to be about 8 months. This study will be
      prospectively conducted as a randomized controlled study with aspirin treated patients who
      received metal stents in patients over 20 years who were confirmed malignant distal biliary
      obstruction. The primary endpoint is the incidence of stent dysfunction in both groups for 6
      months after the procedure. The secondary endpoints included duration of metallic stent
      patency, incidence of further procedures, and adverse events related with aspirin.
Background -Endoscopic drainage is the first choice for bile drainage in patients with
      malignant distal biliary obstruction. Metal stents are mainly used for malignant biliary
      obstruction if the surgical treatment is not considered. Metal stents have proven superior in
      many clinical aspects over plastic stents. Nonetheless, the maintenance period of the
      metallic stent patency has been reported to be around 8 months, and it is often necessary to
      undergo further procedure due to dysfunction of stents. Recently, it has been reported that
      the duration of the metallic stent patency in patients with aspirin is prolonged. Since the
      previous study was a retrospective study, this study will be prospectively conducted as a
      randomized controlled study with aspirin treated patients who received metal stents in
      patients over 20 years who were confirmed malignant distal biliary obstruction. The incidence
      of stent dysfunction in both groups for 6 months after the procedure will be compared. Stent
      dysfunction is defined as any case which further procedure is required due to jaundice or
      cholangitis after stent insertion.

      Study aim

      -The aim of this study is to determine whether administration of aspirin can help maintain
      the patency of metallic stents for distal malignant common bile duct obstruction.

      Data analysis

        -  Blinding will remain in place until the statistician codes the statistical analyses of
           the primary and secondary outcomes. The statistical analyses will be done using the full
           analysis set according to the intention-to-treat principle, meaning all the randomized
           patients will be analyzed in their allocated groups regardless of any protocol
           violations or early treatment discontinuations. The outcomes through a per-protocol
           analysis set that will consider only the subjects who followed the protocol effectively
           will be analyzed.

        -  The rate of stent dysfunction will be compared using Pearson's chi-squared test with
           Fisher's exact test and calculated the odds ratio of the event. The secondary outcomes
           (i.e., the duration of stent patency, the rate of reintervention, and the adverse events
           related to aspirin administration) will be analyzed using Pearson's chi-squared test
           with Fisher's exact test, Student's t-test, and Kaplan-Meier curves stratified by drug
           and the hazard ratios between two groups using the Cox proportional hazards. The further
           affecting factors for stent dysfunction will be assessed by univariable and
           multivariable logistic regression analysis.

        -  In the initial plan, it was decided not to perform interim analysis, but it was
           confirmed that more adverse events occurred than expected in the process of conducting
           the study. Therefore, the interim analysis was performed with the data up to May 2020,
           and determine whether to continue the study by measuring the benefits and losses
           obtained from aspirin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blind
measure: Incidence of stent dysfunction
time frame: 6 months after biliary metalic stent
description: Dysfunction after 6 months from stenting
measure: Duration of metalic stent patency
time frame: 6 months after biliary metalic stent
description: Duration from insertion time to metallic stent dysfunction time
measure: Incidence of further procedures
time frame: 6 months after biliary metalic stent
description: Incidence of further procedures needed for biliary drainage
measure: Adverse events related with aspirin
time frame: 6 months after biliary metalic stent
description: Adverse events which clearly related with aspirin admistration including bleeding event
arm group label: Intervention
arm group type: Experimental
description: Intervention : aspirin medication Case with aspirin medication for 6 months after stenting
arm group label: Control
arm group type: Placebo Comparator
description: Control : placebo medication Case with placebo medication for 6 months after stenting
intervention type: Drug
intervention name: Aspirin
description: Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction
arm group label: Intervention
other name: Aspirin 100 mg
intervention type: Drug
intervention name: Placebo
description: Case with placebo medication for 6 months after stenting
arm group label: Control
other name: Placebo drug of aspirin
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Woo Hyun Paik, MD, PhD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Woo Hyun Paik
investigator title: Professor
mesh term: Cholestasis
mesh term: Cholestasis, Extrahepatic
mesh term: Aspirin
sharing ipd: Undecided