<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/NCT02193789</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-MDB-14-059</org_study_id>
    <nct_id>NCT02193789</nct_id>
  </id_info>
  <brief_title>Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration</brief_title>
  <official_title>The Effect of Newly Designed Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration in Benign Stricture of Gastroduodenal Anastomosis: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis&#xD;
      site stricture is very severe complication. It can improve by temporary through the scope&#xD;
      covered metallic stent. It is very effective procedure about the stricture. But stent&#xD;
      migration is very severe complication. Herein the investigators suggest newly method to&#xD;
      prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent&#xD;
      stent migration. But it is difficult to remove stent after resolved stricture. So the&#xD;
      investigators add the suture between hemoclip and stent. And the investigators cut the suture&#xD;
      when stent removal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2015</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>Improvement of symptom (Resolving anastomosis site stricture)</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Improvement of food intake. It was measured by the gastric outlet obstruction scoring system (GOOSS) score, with 0 = no oral intake, 1 = liquid diet, 2 = soft diet, and 3 = regular diet.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications associated with the procedure</measure>
    <time_frame>Up to 1 month (time of stent removal)</time_frame>
    <description>Check all the complications associated with the procedure (e.g. procedure failure, stent migration, no improvement of symptom, etc.)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Gastroduodenal Anastomosis</condition>
  <arm_group>
    <arm_group_label>Anastomosis site stricture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>deployment of through the scope covered metallic stent at the stricture site</intervention_name>
    <description>Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site</description>
    <arm_group_label>Anastomosis site stricture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Covered Self-expandable Metallic Stents</intervention_name>
    <arm_group_label>Anastomosis site stricture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subtotal gastrectomy with Billroth-I or Billroth-II anastomosis&#xD;
&#xD;
          -  symptom of gastric outlet obstruction&#xD;
&#xD;
          -  anastomosis site stricture after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients of the impossible stent insertion due to other complication&#xD;
&#xD;
          -  foreigner&#xD;
&#xD;
          -  no agree a concent&#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>Sun Gyo Lim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ki Seong Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joon Koo Kang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajou university hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeong-gi do</state>
        <zip>443-380</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <zip>443-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>February 19, 2016</last_update_submitted>
  <last_update_submitted_qc>February 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Kee Myung Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Anastomosis site structure</keyword>
  <keyword>Stent insertion</keyword>
  <keyword>Stent migration</keyword>
  <pending_results>
    <submitted>July 6, 2020</submitted>
    <returned>July 20, 2020</returned>
  </pending_results>
  <!-- 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/NCT02193789
org study id: AJIRB-MED-MDB-14-059
nct id: NCT02193789
lead sponsor: 
has dmc: Yes
In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis
      site stricture is very severe complication. It can improve by temporary through the scope
      covered metallic stent. It is very effective procedure about the stricture. But stent
      migration is very severe complication. Herein the investigators suggest newly method to
      prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent
      stent migration. But it is difficult to remove stent after resolved stricture. So the
      investigators add the suture between hemoclip and stent. And the investigators cut the suture
      when stent removal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement of symptom (Resolving anastomosis site stricture)
time frame: Up to 1 month
description: Improvement of food intake. It was measured by the gastric outlet obstruction scoring system (GOOSS) score, with 0 = no oral intake, 1 = liquid diet, 2 = soft diet, and 3 = regular diet.
measure: Complications associated with the procedure
time frame: Up to 1 month (time of stent removal)
description: Check all the complications associated with the procedure (e.g. procedure failure, stent migration, no improvement of symptom, etc.)
arm group label: Anastomosis site stricture
arm group type: Experimental
description: anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis
intervention type: Procedure
intervention name: deployment of through the scope covered metallic stent at the stricture site
description: Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site
arm group label: Anastomosis site stricture
intervention type: Device
intervention name: Covered Self-expandable Metallic Stents
arm group label: Anastomosis site stricture
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Sun Gyo Lim, M.D.
role: Principal Investigator
affiliation: Ajou University School of Medicine
last name: Ki Seong Lee, M.D.
role: Principal Investigator
affiliation: Ajou University School of Medicine
last name: Joon Koo Kang, M.D.
role: Principal Investigator
affiliation: Ajou University School of Medicine
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Kee Myung Lee
investigator title: Professor
submitted: July 6, 2020
returned: July 20, 2020