<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/NCT04494919</url>
  </required_header>
  <id_info>
    <org_study_id>UFE-1.0</org_study_id>
    <nct_id>NCT04494919</nct_id>
  </id_info>
  <brief_title>Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope</brief_title>
  <official_title>Two Different Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ningbo No. 1 Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ningbo No. 1 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>
      Colorectal cancer is the third most common cancer worldwide and results in 8-25% acute&#xD;
      malignant bowel obstruction. Since Dohmoto et al. first applied and reported the&#xD;
      self-expanding metal stents (SEMS) in the treatment of colorectal stenosis, they have been&#xD;
      widely used not only as an alternative treatment as a bridge to surgery (BTS), but also as a&#xD;
      mean of palliative option for stenosing lumen in clinical practice. Numerous publications&#xD;
      have reported that the stent placement technique showed 75% to 100% technical success rates&#xD;
      and 84% to 100% clinical success rates. However, it is sometimes difficult to place due to&#xD;
      the distorted anatomy or acute angulations in patients and other conditions with poor&#xD;
      endoscopic visualization with the normal colonoscope. The aims of this study were to present&#xD;
      our results with two novel SEMS implantation techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The technical success rate</measure>
    <time_frame>1 hour</time_frame>
    <description>the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The clinical success rate</measure>
    <time_frame>24 hours</time_frame>
    <description>the ratio between the patients with regressive signs and symptoms of obstruction (within 24 h) and those succeeded for SEMS implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The adverse events rate</measure>
    <time_frame>2 year</time_frame>
    <description>the ratio between the patients with adverse events (like perforation, bleeding, and reobstruction) and those succeeded for SEMS implantation.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Ultrafine Endoscope Assisted</arm_group_label>
    <description>The self-expanding metal stent (SEMS) implantation was conducted using an ultrafine endoscope (UFE) (GIF-XP260NS; Olympus, Tokyo, Japan). The UFE researched the stricture, and a guidewire was inserted into the endoscopic working channel. The guidewire was left. And the endoscope was withdrawn. The normal colonoscope was exchanged under the reverse guidance of the guidewire. Finally, a metal, uncovered SEMS was placed along the guidewire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrafine Endoscope</intervention_name>
    <description>The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).</description>
    <arm_group_label>Ultrafine Endoscope Assisted</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with colorectal stricture underwent novel intestinal stent implantation methods&#xD;
        assised by ultrafine endoscope.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Patients with colorectal cancer stenosis&#xD;
&#xD;
          -  Patients with intestinal stent implantation in digital subtraction angiography room&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing conventional intestinal stent implantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ningbo first hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT04494919
org study id: UFE-1.0
nct id: NCT04494919
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer is the third most common cancer worldwide and results in 8-25% acute
      malignant bowel obstruction. Since Dohmoto et al. first applied and reported the
      self-expanding metal stents (SEMS) in the treatment of colorectal stenosis, they have been
      widely used not only as an alternative treatment as a bridge to surgery (BTS), but also as a
      mean of palliative option for stenosing lumen in clinical practice. Numerous publications
      have reported that the stent placement technique showed 75% to 100% technical success rates
      and 84% to 100% clinical success rates. However, it is sometimes difficult to place due to
      the distorted anatomy or acute angulations in patients and other conditions with poor
      endoscopic visualization with the normal colonoscope. The aims of this study were to present
      our results with two novel SEMS implantation techniques.
observational model: Case-Only
time perspective: Retrospective
measure: The technical success rate
time frame: 1 hour
description: the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.
measure: The clinical success rate
time frame: 24 hours
description: the ratio between the patients with regressive signs and symptoms of obstruction (within 24 h) and those succeeded for SEMS implantation.
measure: The adverse events rate
time frame: 2 year
description: the ratio between the patients with adverse events (like perforation, bleeding, and reobstruction) and those succeeded for SEMS implantation.
arm group label: Ultrafine Endoscope Assisted
description: The self-expanding metal stent (SEMS) implantation was conducted using an ultrafine endoscope (UFE) (GIF-XP260NS; Olympus, Tokyo, Japan). The UFE researched the stricture, and a guidewire was inserted into the endoscopic working channel. The guidewire was left. And the endoscope was withdrawn. The normal colonoscope was exchanged under the reverse guidance of the guidewire. Finally, a metal, uncovered SEMS was placed along the guidewire.
intervention type: Device
intervention name: Ultrafine Endoscope
description: The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).
arm group label: Ultrafine Endoscope Assisted
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Colorectal Neoplasms