<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/NCT03761667</url>
  </required_header>
  <id_info>
    <org_study_id>NASA</org_study_id>
    <nct_id>NCT03761667</nct_id>
  </id_info>
  <brief_title>Usefulness of NBI for Complete Endoscopic Resection of SSA/P</brief_title>
  <official_title>Usefulness of Narrow Band Imaging (NBI) for Complete Endoscopic Resection of Sessile Serrated Adenoma/Polyp (SSA/P): NASA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <brief_summary>
    <textblock>
      This study is a prospective randomized study to evaluate the role of NBI for improving&#xD;
      complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll&#xD;
      consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. The&#xD;
      authors will inspect resection margin of SSA/P using white light endosocpy (WLE) or NBI after&#xD;
      randomization for the evaluation of remnant lesion. Additional resection will be performed&#xD;
      for suspicious of remnant lesion, and then 4 biopsies from 4 quadrants of margin for&#xD;
      evaluation of complete resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective randomized multi-center study to evaluate the role of NBI for&#xD;
      improving complete resection rate of sessile serrated adenoma/polyp (SSA/P).&#xD;
&#xD;
      The authors will enroll consecutive patients who underwent colon polypectomy for suspicious&#xD;
      SSA/P during colonoscopy.&#xD;
&#xD;
      All patients who undergo polypectomy will be enrolled, but excluded as follows; 1. poor bowel&#xD;
      preparation according to Boston bowel preparation scale calculation, 2. inflammatory bowel&#xD;
      disease, 3. failure of cecal insertion, 4. continuous anti-plate agents or anti-coagulation&#xD;
      agents users.&#xD;
&#xD;
      First, the authors will inspect polyp using the arbitrary endoscopic criteria by inspection&#xD;
      of white light endoscopy (WLE) and if that lesion is satisfied with 3 or more than 3 out of 5&#xD;
      categories (1. located in the right colon, 2. flat shape, 3. covered with mucus cap or&#xD;
      debris, 4. 1 cm or larger than 1 cm in size, 5. varicose superficial vessel was seen on the&#xD;
      surface after submucosal injection), endoscopic resection will be performed.&#xD;
&#xD;
      And then, the authors will inspect the resection margin carefully using NBI or WLE by&#xD;
      pre-randomization before endoscopic resection. If the remnant tissue is detected, additional&#xD;
      endoscopic resection will be performed.&#xD;
&#xD;
      ed margin as two groups (NBI inspection group and WLE inspection&#xD;
&#xD;
      And then, 4 biopsies from 4 quadrants of margin for evaluation of complete resection.&#xD;
&#xD;
      Primary end-point is comparing the rate of additional resection for remnant lesion, the SSA/P&#xD;
      diagnosis rate of the remnant lesions after the additional resection, and the complete&#xD;
      resection rate of the target lesion between two groups.&#xD;
&#xD;
      Secondary aim is evaluate the accuracy for SSA/P using arbitrary WLE criteria. For evaluation&#xD;
      of the accuracy of arbitrary WLE criteria, the authors will compare the pathologic diagosis&#xD;
      rate of SSA/P for each criterion, and calculate the sensitivity, the specificity, the&#xD;
      positive predictive value, the negative predictive value, and the accuracy with area under&#xD;
      curve of ROC.&#xD;
&#xD;
      The authors hypothesized complete resection rate of SSA/P as 90% in the NBI inspection group&#xD;
      and 70% in the WLE inspection group based on previous studies including CARE study.&#xD;
&#xD;
      The sample size was calculated as 118 (each 59) patients of SSA/P. Study duration will be 2&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2015</start_date>
  <completion_date type="Actual">November 25, 2018</completion_date>
  <primary_completion_date type="Actual">November 10, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the detection rate of remnant lesion,</measure>
    <time_frame>2 years after IRB</time_frame>
    <description>Comparing the detection rate of remnant SSA/P right after the endoscopic resection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The diagnosis rate of SSA/P in the remnant tissue</measure>
    <time_frame>2 years after IRB</time_frame>
    <description>Pathologic diagnosis rate of SSA/P after the additional endoscopic resection of the remnant tissue detected by NBI or WLE right after the endoscopic resection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incomplete resection rate of SSA/P</measure>
    <time_frame>2 years after IRB</time_frame>
    <description>Compare the incomplete resection rate of SSA/P using four directional biopsied on the resection margin after the endoscopic resection including additional resection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of arbitrary endoscopic criteria for SSA/P inspection by white light endoscopy</measure>
    <time_frame>2 years after IRB</time_frame>
    <description>In this study, the authors made the arbitrary endoscopic criteria for suspicion of SSA/P by inspection of WLE.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Sessile Serrated Adenoma/Polyps</condition>
  <arm_group>
    <arm_group_label>NBI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group of NBI inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White light endoscopy (WLE)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The group of WLE inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endoscopy using Narrow band imaging</intervention_name>
    <description>Inspection of resection margin of SSA/P for the evaluation of complete resection or the presence of remnant lesion using NBI method</description>
    <arm_group_label>NBI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Colonoscopy examinee with suspicious SSA/P&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor bowel preparation (total Boston bowel preparation scale &lt; 6 or any region score &lt;&#xD;
             2)&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  failed cecal insertion of colonoscopy&#xD;
&#xD;
          -  continuous taking anticoagulation or anti-platelet drugs until on the procedure day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Hyun Gun, Kim. M.D., Ph.D.</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Polyps</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/NCT03761667
org study id: NASA
nct id: NCT03761667
lead sponsor: 
This study is a prospective randomized study to evaluate the role of NBI for improving
      complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll
      consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. The
      authors will inspect resection margin of SSA/P using white light endosocpy (WLE) or NBI after
      randomization for the evaluation of remnant lesion. Additional resection will be performed
      for suspicious of remnant lesion, and then 4 biopsies from 4 quadrants of margin for
      evaluation of complete resection.
This study is a prospective randomized multi-center study to evaluate the role of NBI for
      improving complete resection rate of sessile serrated adenoma/polyp (SSA/P).

      The authors will enroll consecutive patients who underwent colon polypectomy for suspicious
      SSA/P during colonoscopy.

      All patients who undergo polypectomy will be enrolled, but excluded as follows; 1. poor bowel
      preparation according to Boston bowel preparation scale calculation, 2. inflammatory bowel
      disease, 3. failure of cecal insertion, 4. continuous anti-plate agents or anti-coagulation
      agents users.

      First, the authors will inspect polyp using the arbitrary endoscopic criteria by inspection
      of white light endoscopy (WLE) and if that lesion is satisfied with 3 or more than 3 out of 5
      categories (1. located in the right colon, 2. flat shape, 3. covered with mucus cap or
      debris, 4. 1 cm or larger than 1 cm in size, 5. varicose superficial vessel was seen on the
      surface after submucosal injection), endoscopic resection will be performed.

      And then, the authors will inspect the resection margin carefully using NBI or WLE by
      pre-randomization before endoscopic resection. If the remnant tissue is detected, additional
      endoscopic resection will be performed.

      ed margin as two groups (NBI inspection group and WLE inspection

      And then, 4 biopsies from 4 quadrants of margin for evaluation of complete resection.

      Primary end-point is comparing the rate of additional resection for remnant lesion, the SSA/P
      diagnosis rate of the remnant lesions after the additional resection, and the complete
      resection rate of the target lesion between two groups.

      Secondary aim is evaluate the accuracy for SSA/P using arbitrary WLE criteria. For evaluation
      of the accuracy of arbitrary WLE criteria, the authors will compare the pathologic diagosis
      rate of SSA/P for each criterion, and calculate the sensitivity, the specificity, the
      positive predictive value, the negative predictive value, and the accuracy with area under
      curve of ROC.

      The authors hypothesized complete resection rate of SSA/P as 90% in the NBI inspection group
      and 70% in the WLE inspection group based on previous studies including CARE study.

      The sample size was calculated as 118 (each 59) patients of SSA/P. Study duration will be 2
      years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the detection rate of remnant lesion,
time frame: 2 years after IRB
description: Comparing the detection rate of remnant SSA/P right after the endoscopic resection
measure: The diagnosis rate of SSA/P in the remnant tissue
time frame: 2 years after IRB
description: Pathologic diagnosis rate of SSA/P after the additional endoscopic resection of the remnant tissue detected by NBI or WLE right after the endoscopic resection.
measure: Incomplete resection rate of SSA/P
time frame: 2 years after IRB
description: Compare the incomplete resection rate of SSA/P using four directional biopsied on the resection margin after the endoscopic resection including additional resection
measure: Accuracy of arbitrary endoscopic criteria for SSA/P inspection by white light endoscopy
time frame: 2 years after IRB
description: In this study, the authors made the arbitrary endoscopic criteria for suspicion of SSA/P by inspection of WLE.
arm group label: NBI
arm group type: Experimental
description: The group of NBI inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.
arm group label: White light endoscopy (WLE)
arm group type: No Intervention
description: The group of WLE inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.
intervention type: Other
intervention name: Endoscopy using Narrow band imaging
description: Inspection of resection margin of SSA/P for the evaluation of complete resection or the presence of remnant lesion using NBI method
arm group label: NBI
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Hyun Gun, Kim. M.D., Ph.D.
investigator title: Associate professor
mesh term: Adenoma
mesh term: Polyps